Label: ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE- zinc oxide and dimethicone 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 August 9, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient        Purpose
    Zinc Oxide (200 mg)      Diaper Rash
    Dimethicone 1.8%         Skin Protectant

  • Purpose:

    • Helps treat and prevent diaper rash.
    • Dries the oozing and weeping of
    • poison ivy
    • poison oak
    • poison sumac

  • Warnings:

    For external use only

  • Dosage and Administration:

    For diaper rash

    • 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 often as needed
  • Other information

    • Do not use if seal is punctured or not visible
    • store at room temperature 15°-30° C (59°-86° F)
    • avoid excessive heat
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Cholecaliferol, Diazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Purified Water, Retinyl Palmitate, Sodium Borate, Stearic Acid, Tocopheryl Acetate, Yellow 5, Yellow 6, Zea Mays (Corn) oil

  • Stop use if

    • conditions worsen
    • symptoms last more than 7 days or clear up and occur in a few days, consult a physician
    • over large areas of the body
    • if you are allergic to these ingredients
  • Indications and Usage

    Indications are for diaper rash and general skin protectant.

  • Do not use

    • deep or puncture wounds
    • animal bites
    • serious burns
  • 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.
  • Principal Display Panel

    GalShield with Dimethicone

    GalShield D.jpg

    Galshield

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE AND DIMETHICONE  WITH DIMETHICONE
    zinc oxide and dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE18 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    VITAMIN A (UNII: 81G40H8B0T)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-012-01113.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/08/2013
    Labeler - Galentic Pharma (India) Private Limited (918531450)