Label: VITAMIN A AND D cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 4, 2016

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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)