Label: MOISTURE THERAPY ANTI-ITCH- menthol spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 2, 2014

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  • ACTIVE INGREDIENT

    Active ingredient
    Menthol 0.5 %......

           Purpose
    .........External Analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations.

  • WARNINGS

    Warnings
    For external use only

    When using this product

    • avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 2 years of age and older:

    • apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age:

    • consult a doctor before use
  • INACTIVE INGREDIENT

    Inactive Ingredients:
    WATER/EAU, C12-15 ALKYL BENZOATE, ETHYLHEXYL PALMITATE, GLYCERIN, SD ALCOHOL 40-B, BUTYLENE GLYCOL, GLYCERYL STEARATE,
    CETEARETH-20, AVENA SATIVA (OAT) MEAL EXTRACT, CITRIC ACID, CETEARETH-12, CETEARYL ALCOHOL, CETYL PALMITATE, CHOLESTEROL, CHLORPHENESIN, SODIUM HYDROXIDE, SODIUM DEHYDROACETATE.

  • QUESTIONS

    Questions?
    Call 1-800-FOR-AVON or 1-800-265-AVON in Canada.

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFBimage of DFBimage of DFB

  • INGREDIENTS AND APPEARANCE
    MOISTURE THERAPY  ANTI-ITCH
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0146-160 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/26/2012
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture(10096-0146)
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