Label: ASTRINGENT- aluminum acetate gel

  • 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 1, 2015

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  • WARNINGS

    For external use only. Avoid contact with eyes. Keep out of reach of children. Do not apply to open wounds. STOP USE AND ask a doctor if condition worsens or symptoms persist for more than seven days, discontinue use of the product.

  • DOSAGE & ADMINISTRATION

    Adults and children two years of age and older, apply to affected area not more than three times daily or as directed by a doctor. 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,
    Purified Water,
    Strontium Chloride Hexahydrate,
    Xanthan Gum.

  • PURPOSE

    Astringent

  • ACTIVE INGREDIENT

    1. Aluminium acetate
  • KEEP OUT OF REACH OF CHILDREN

    For external use only.
    Avoid contact with eyes.
    Keep out of reach of children.
    Do not apply to open wounds.
    STOP USE AND ask a doctor if condition worsens or
    symptoms persist for more than seven days, discontinue
    use of the product.

  • INDICATIONS & USAGE

    1. Adults and children two years of age and older, apply to affected area not more than three times daily or as directed by a doctor. Consult a physician for children under the age of two.

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    ASTRINGENT 
    aluminum acetate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE0.008 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Dehydroacetic Acid (UNII: 2KAG279R6R)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycine (UNII: TE7660XO1C)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Malic Acid (UNII: 817L1N4CKP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Water (UNII: 059QF0KO0R)  
    Strontium Chloride Hexahydrate (UNII: O09USB7Z44)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-005-044 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2015
    Labeler - CA-BOTANA INTERNATIONAL (106276728)
    Registrant - RODOLFO UGELSTAD (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-BOTANA INTERNATIONAL106276728manufacture(35192-005)
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