Label: TRICALM HYDROGEL- aluminum acetate gel

  • NDC Code(s): 71207-221-02
  • Packager: MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • ACTIVE INGREDIENT

    Aluminum acetate 0.2%

  • PURPOSE

    Astringent

  • INDICATIONS & USAGE

    For the temporary relief of minor skin irritations due to:

    • poison ivy
    • poison oak
    • poison sumac
    • insect bites
    • rashes caused by soaps, detergents, cosmetics, or jewelry
    • athlete's foot
  • WARNINGS

    For external use only.

    When using this product avoid contact with eyes; if contact occurs, rinse thoroughly with water

    Stop use and ask a doctor if condition worsens or symptoms last for more than 7 days

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    • adults and children two years of age and older, apply to affected areas as needed or as directed by a physician
    • consult a physician for children under the age of two
  • INACTIVE INGREDIENT

    butylene glycol, caprylyl glycol, dehydroacetic acid, ethylhexylglycerin, glycine, hexylene glycol, malic acid, phenoxyethanol, strontium chloride hexahydrate, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    TRICALM HYDROGEL 
    aluminum acetate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71207-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCINE (UNII: TE7660XO1C)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MALIC ACID (UNII: 817L1N4CKP)  
    STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71207-221-021 in 1 CARTON01/02/2023
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/02/2023
    Labeler - MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES (131710969)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(71207-221)
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