Label: TRICALM EXTRA STRENGTH- aluminum acetate solution

  • 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 July 1, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Aluminum acetate (0.3%)

  • Purpose

    Astringent

  • Uses

    For temporary relief of minor skin irritations due to:

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

    For external use only.

    When using this product

    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • Do not apply to open wounds.
    • Temporary stinging may occur when applied to extremely dry, open or abraded skin.

    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.
  • Directions

    • Adults and children two years of age and older, apply to affected area as needed or as directed by a physician. Consult a physician for children under the age of two.
  • Inactive ingredients

    Butylene glycol, caprylyl glycol, edetate disodium, glycerin, lactic acid, phenoxyethanol, polysorbate 80, purified water, strontium nitrate.

  • Questions?

    Call 855-TRI-CALM

  • PRINCIPAL DISPLAY PANEL - 55 mL Tube Box

    EXTRA STRENGTH SPRAY

    TRICALM®

    FOR ITCHING, BURNING AND STINGING

    1.86 FL OZ (55mL)

    Principal Display Panel - 55 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    TRICALM   EXTRA STRENGTH
    aluminum acetate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76312-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Acetate (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) Aluminum Acetate3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    STRONTIUM NITRATE (UNII: BDG873AQZL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76312-002-011 in 1 BOX
    155 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34703/01/2015
    Labeler - Cosmederm Bioscience (054730518)
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