Label: CMC SHIELD SKIN PROTECTANT- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 12, 2017

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  • ACTIVE INGREDIENT

    Zinc Oxide (3.8%)

  • PURPOSE

    Skin Protectant

  • USES

    • helps treat and prevent diaper rash
    • temporarily protects from 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

    Condition worsens or 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 a room temperature 15-30° C (59-86 F)
    • 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 DISPLAYDRUG FACT PANEL

  • INGREDIENTS AND APPEARANCE
    CMC SHIELD SKIN PROTECTANT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71168-3066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A (UNII: 81G40H8B0T)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71168-3066-499.2 g in 1 TUBE; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2017
    Labeler - SKYLARK CMC PRIVATE LIMITED (650174824)
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