DR. SMARTH ALOE SOFT VITAMIN ENRICHED (ZINC OXIDE) CREAM [CRYSTAL CURAM]

DR. SMARTH ALOE SOFT VITAMIN ENRICHED (ZINC OXIDE) CREAM [CRYSTAL CURAM]
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NDC 72886-3066-4
Set ID 81785daa-1ceb-6291-e053-2991aa0a7ddd
Category HUMAN OTC DRUG LABEL
Packager Crystal Curam
Generic Name
Product Class
Product Number
Application Number PART347
  • Active Ingredient

    Zinc Oxide (3.8%w/w)

  • Purpose

    Skin Protectant

  • Uses

    ■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

  • Warnings

    For external use only

  • When using this product

    ■ do not get into eyes

  • Stop Use and ask a doctor if

    conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

  • Keep out of reach of children

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

  • Directions

    ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

  • Other Information

    ■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

  • Inactive ingredients

    aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender
    methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium
    steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

  • Package Label

    Principal Display

  • INGREDIENTS AND APPEARANCE
    DR. SMARTH  ALOE SOFT VITAMIN ENRICHED
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72886-3066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A (UNII: 81G40H8B0T)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72886-3066-499.2 g in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2019
    Labeler - Crystal Curam (675483147)

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