Label: FOOT WORKS ACHY FOOT MASSAGER PAIN RELIEVING- menthol lotion
- NDC Code(s): 10096-0288-1
- Packager: Avon Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
• 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
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
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.Close
Children under 2 years of age:
• consult a doctor
- INACTIVE INGREDIENT
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.Close
Call 1-800-FOR AVONClose
- INGREDIENTS AND APPEARANCE
FOOT WORKS ACHY FOOT MASSAGER PAIN RELIEVING
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0288 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 13.5 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0288-1 75 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/25/2012 Labeler - Avon Products, Inc. (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc. 005149471 manufacture(10096-0288)