VITAMIN A AND D CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]

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VITAMIN A AND D CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]
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NDC 52000-026-37, 52000-026-39
Set ID 8b27b78a-1f8c-4a0b-a265-dbb3c4fabdbc
Category HUMAN OTC DRUG LABEL
Packager Universal Distribution Center LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active Ingredients

    Vitamin A  181.8 IU

    Vitamin D   1200 IU

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    • helps prevent diaper rash
    • heals dry, flaky and chafed skin
    • soothes and protects minor cuts and burns
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use in eyes

    • not for extensive burns or serious cuts, consult a physician
  • STOP USE

    Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases or if infection develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously and massage until absorbed. Repeat as necessary.
  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF). Lot No. & Exp.Date see crimp of tube.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Cetyl Alcohol, DMDM Hydantoin, Glyceryl Monostearate, Methylparaben, Mineral Oil, Polysorbate 20, Propylparaben, Stearic Acid,  Trisodium EDTA, and Water.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Vitamin A&D Cream

    NET WT 1 OZ (28 g)

    image of package label

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    vitamin a and d cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A181.8 [iU]  in 1 g
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D1200 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-026-371 in 1 CARTON08/04/2016
    1NDC:52000-026-3928 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34708/04/2016
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-026)
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