UNIMMAP Formula, Packaging, and Labeling Guidance

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UNIMMAP Formula, Packaging, and Labeling Guidance
UNIMMAP Formula,
Packaging, and Labeling
      Guidance
UNIMMAP Formula, Packaging, and Labeling Guidance
Contents
UNIMMAP MMS Formula....................................................................................................... 3
Packaging Specifications ..................................................................................................... 4
Labeling Specifications ........................................................................................................ 5
UNIMMAP Formula, Packaging, and Labeling Guidance
UNIMMAP MMS Formula

               Ingredient                Label Claim          Reference
  Vitamin A (as Retinyl Acetate)         800 mg RAE           USP-NF 41:
                                          (2667 IU)     Oil- and Water- Soluble
  Vitamin C (as Ascorbic Acid)              70 mg       Vitamins with Minerals
                                                                Tablets
  Vitamin D (as Cholecalciferol)           5 mcg
                                          (200 IU)      Per USP General Notice
  Vitamin E (as d-Alpha Tocopheryl                           4.10.20, ito be in
                                         10 mg α-TE     compliance with US FDA
  Succinate)
                                                         (cGMP 21 CFR 101.9)
  Vitamin B1 (as Thiamine Mononitrate)     1.4 mg      guidelines, the Lower Limit
                                                       for all ingredients is 100%
  Vitamin B2 (Riboflavin)                  1.4 mg      rather than 90% as stated
                                                          in the Oil- and Water-
                                                          Soluble Vitamins with
  Vitamin B3 (Niacinamide)               18.0 mg NE
                                                             Minerals Tablets
                                                                Monograph.
  Vitamin B6 (as Pyridoxine HCl)           1.9 mg

  Folate (as Folic Acid)                 667 mcg DFE
                                          (400 mcg)
  Vitamin B12 (as Cyanocobalamin)           2.6 µg

  Iron (as Ferrous Fumarate)                30 mg

  Iodine (as Potassium Iodide)            150.0 mcg

  Zinc (as Zinc Oxide)                     15.0 mg

  Selenium (as Sodium Selenite)           65.0 mcg

  Copper (as Cupric Oxide)                 2.0 mg
Packaging Specifications
Bottle
   •     Tablets per bottle: 180
   •     Weight: 107 g
   •     Expiration: 30-month
   •     Opaque (HDPE) material
   •     Tamper-evident
   •     Child resistant
   •     Desiccant (1-gram canister)

Box
   •     Weight: 10.7 kg
   •     Bottles per box: 90
   •     Includes instructional sheet

Pallet
   • Weight: 408 kg
   • Boxes per pallet: 36
   • Dimensions: 48” x 40” x 39.625”

 Manufacturer Information
  • Contract Pharmacal Corporation of Hauppauge, N.Y.
  • Certificate of current good manufacturing practices (cGMP) for dietary
     supplements (21 CFR part 111) by a stringent regulatory authority

 Other Information
   • UNIMMAP – MMS provided by Kirk Humanitarian is classified by USFDA as a
      dietary supplement
   • This product is Halal-certified and comes with a certificate from IFANCA
   • Certificate of origin; freesale are provided with shipment
   • Certificate of analysis is provided with shipment
Labeling Specifications
  •   USP designation of UNIMMAP – MMS Product delivered by KH: oil- and water-
      soluble vitamins with minerals tablets
  •   USP verification mark in progress
  •   30-month shelf life
  •   Zone IVB climatic conditions
  •   Dietary Supplement Panel

                                                                                                                                                                   OTHER
                           DIRECTIONS: Take only one                                                    Supplement Facts                                           INGREDIENTS:
                           tablet daily by mouth.                                                       Serving Size: 1 Tablet
                                                                                                                                                                   Microcrystalline
                           STORAGE: Store between                                                       Amount Per Serving                          %Daily Value* Cellulose, Dicalcium
                                                                                                                                                               62% Phosphate,

                                                                     Multiple
                           15°-30°C in a dry place.                                                     Vitamin A (as Retinyl Acetate)           800 mcg RAE
                           Keep bottle tightly closed.                                                  Vitamin C (as Ascorbic Acid)                    70 mg  58% Croscarmellose
                                                                                                        Vitamin D (as Cholecalciferol)          5 mcg (200 IU) 33%
                                                                                                                                                                   Sodium, Magnesium

                                                                   Micronutrient                        Vitamin E (as d-α-Tocopheryl Succinate)    10 mg α-TE  53%
                                                                                                                                                                   Stearate, Silica, Starch,
       WARNING: Accidental overdose of iron-containing                                                  Vitamin B-1 (as Thiamine Mononitrate)          1.4 mg 100%
                                                                                                                                                                   Polyvinylpyrrolidone,
                                                                                                                                                                   Sucrose, Acacia,
         products is a leading cause of fatal poisoning in
        children under 6. Keep this product out of the             Supplement                           Vitamin B-2 (Riboflavin)
                                                                                                        Vitamin B-3 (as Niacinamide)
                                                                                                                                                       1.4 mg  88%
                                                                                                                                                    18 mg NE 100%
                                                                                                                                                                   Crospovidone,
                                                                                                                                                                   Hypromellose,
       reach of children. In case of accidental overdose,
                                                                                  for                   Vitamin B-6 (as Pyridoxine HCl)                1.9 mg  95%
                                                                                                                                                                   Polyethylene Glycol,

                                                                       Pregnant
       call a doctor or poison control center immediately.                                              Folate (as Folic Acid)         680 mcg DFE (400 mcg) 113% Triglycerides,

                                                                                                                                                                                                                      EXP DATE:
                                                                                                        Vitamin B-12 (as Cyanocobalamin)              2.6 mcg  93% Tocopherols, Sodium

                                                                                                                                                                                                            LOT # :
                                                                        Women
                                                                                                        Iron (as Ferrous Fumarate)                      30 mg 111% Ascorbate and
                                  USP has tested and verified                                           Iodine (as Potassium Iodide)                  150 mcg  52% Tricalcium
                                                                                                                                                                                          Manufactured by
                                   ingredients, potency, and                                            Zinc (as Zinc Oxide)                            15 mg 115% Phosphate.             Contract Pharmacal Corp.,
                                    manufacturing process.                                              Selenium (as Sodium Selenite)               65 mcg     93%                          Hauppauge, NY 11788 USA
                                 USP sets official standards for    UNIMMAP formulation in accordance
                                                                                                        Copper (as Cupric Oxide)                      2 mg    154%                          kirkhumanitarian.org
                                   dietary supplements. See             with WHO specifications                                                                                             ©2021 Kirk Humanitarian,
                                     www.uspverified.org                                                *Daily Value (DV) for Pregnant and Lactating Women,                                 Salt Lake City, UT 84121 USA
                                                                        180 Tablets / Made in USA       as established by the U.S. FDA.                              R50125                 PHONE: 1-801-999-1940
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