Label: FOOT WORKS ACHY FOOT MASSAGER PAIN RELIEVING- menthol lotion

  • 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 February 17, 2016

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  • ACTIVE INGREDIENT

    Active ingredient
    Menthol 1.35%................

    Purpose

    .........Pain relieving lotion

  • INDICATIONS & USAGE

    Uses
    • for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises and sprains
    • provides penetrating pain relief
    • provides cooling pain relief

  • WARNINGS

    Warnings
    For external use only

    When using this product
    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    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

    •Squeeze tube to dispense. Massage gently with roller ball head for 30 seconds or until fully absorbed.
    Children under 2 years of age:
    • consult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    WATER/EAU, SD ALCOHOL 40-B, GLYCERIN, ISOPROPYL PALMITATE, ORYZA SATIVA (RICE) BRAN OIL, MENTHA PIPERITA (PEPPERMINT) OIL, PARFUM/FRAGRANCE, TRIETHANOLAMINE, PHENOXYETHANOL, CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA.

  • QUESTIONS

    Questions?

    Call 1-800-FOR AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of labelimage of label

    image of label

    image of label

  • INGREDIENTS AND APPEARANCE
    FOOT WORKS  ACHY FOOT MASSAGER PAIN RELIEVING
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0288
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL13.5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0288-175 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/25/2012
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture(10096-0288)
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