Label: AFTASEPTIC INSTANT PAIN RELIEF- salisylic acid 1% liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Salicylic Acid 1% w/v

  • Purpose

    Analgesic

  • Uses

    For the temporary relief of pain associated with canker sores.

  • INDICATIONS & USAGE

    for the temporary relief of pain associated with canker sores.

  • Warnings

    Alcohol warning: if you consume 3 or more alcoholic drinks everyday, consult with a specialist whether you should use Salicylic Acid or other pain reliever, fever reducers n Salicylic Acid may cause stomach bleeding.

    Allergy alert: may cause a severe allergic reaction which may include: hives, facial swelling, asthma (wheezing), shock.

  • Warnings

    Flammable n Keep away from fire or flame. Do not use for teething or in children under 2 years of age
    When using this product n avoid contact with eyes. Do not use longer than 1 week unless directed by a doctor. If pregnant or nursing contact a Doctor before using. Stop use and ask a doctor if condition persists or worsen
    keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Other Information

    Store between 15º to 30ºC (59º to 86ºF). Cap bottle tightly. Do not accept if safety seal is broken or missing. Cap bottle tightly. Keep this box for future doubts.

  • Directions

    Use enclosed applicator brush

    Children 14 years of age to adult. Apply 2 brushstrokes 2 times a day to affected area of the mouth, gums or mucous membranes (throat). Do not rinse mouth after use. Children under 14 years of age consult a physician.

  • Inactive Ingredients

    Ethyl Alcohol, propylene glycol, purified water, rhubarb.

  • PRINCIPAL DISPLAY PANEL

    Aftaseptic Aftaseptic

  • INGREDIENTS AND APPEARANCE
    AFTASEPTIC  INSTANT PAIN RELIEF
    salisylic acid 1% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73635-7102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    RHUBARB (UNII: G280W4MW6E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73635-7102-51 in 1 BOX03/29/2019
    114.8 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/29/2019
    Labeler - Germa Products, LLC (116626935)