Label: GERIGARD-SKIN PROTECTANT- zinc oxide ointment

  • 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 January 18, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide (1.8% 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

    • Condition worsens
    • 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

    • Apply liberally as needed
    • For diaper rash:
      • change wet and soiled diapers promptly
      • allow to dry
    • Apply ointment liberally with each diaper change
  • Other information

    • Store at room temperature 15° - 30°C (59° - 86°F)
    • Avoid excessive heat
    • Contains color additives including FD&C Yellow No. 5 (Tartrazine).
  • Inactive ingredients

    Aloe Vera Leaf, Alpha-Tocopherol, Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Ceteth-10, Cetostearyl , Methylparaben, Trolamine, Vitamin A, Water

  • PRINCIPAL DISPLAY PANEL - 113 gm Tube Label

    gerigentle™

    VITAMIN ENRICHED
    geri
    gard™
    SKIN PROTECTANT

    SPECIALLY FORMULATED
    FOR GENTLE SKIN

    AloeSoft

    VITAMIN A • VITAMIN D • VITAMIN E
    ZINC OXIDE • ALOE VERA

    4 FL OZ (113 gm)

    Principal Display Panel - 113 gm Tube Label
  • INGREDIENTS AND APPEARANCE
    GERIGARD-SKIN PROTECTANT 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.8 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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-108-37113 g in 1 TUBE; Type 0: Not a Combination Product01/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34701/15/2009
    Labeler - Geri-Gentle Corporation (361663839)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKYLARK CMC PVT. LTD.650174824MANUFACTURE(69771-108)
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