Label: TENDERGRAN- aluminium hydroxide ointment

  • Category: HUMAN OTC DRUG LABEL

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 December 4, 2022

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  • Active Ingredients:

    Aluminium Hydroxide Gel 2 % w/w

  • Purpose

    Skin Protectant


  • Uses:

    • Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac, or other skin irritations
  • Warnings:

    For external use only.

    ■Deep or puncture wounds ■Animal bites ■Serious burns

    Avoid contact with eyes. In case of contact, flush thoroughly with water

    Stop use and ask a doctor if

    ■Condition worsens

    ■Symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children


    In case of accidental ingestion contact a physician or Poison Control Center right away

  • Directions

    Apply liberally to affected area as needed or as directed by a physician ■Children under 6 months: ask a doctor

  • Other Information


    ■Store at room temperature 15°-30°C (59°-86°F)

  • INACTIVE INGREDIENT

    Calcium Carbonate, Cholecalciferol, Citric Acid, DMDM Hydantoin, Ethylhexylglycerin, Lanolin, Lanolin Alcohol, Magnesium Hydroxide, Petrolatum, Phenoxyethanol, Propylene Glycol, Purified Water, Retinyl Palmitate, Sodium Chloride, Sodium Laureth Sulfate, Stearyl Alcohol, Zea Mays Corn Oil, Zinc Chloride

  • Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    TENDERGRAN 
    aluminium hydroxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CORN OIL (UNII: 8470G57WFM)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-021-23113 g in 1 TUBE; Type 0: Not a Combination Product08/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/17/2022
    Labeler - GERI-GENTLE CORPORATION (080367686)
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