Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Ruggiero Innovations LLC
TOPICAL
OTC DRUG
Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains, etc.
OTC monograph not final
RELIEVE AND RELAX PAIN RELIEVING- MENTHOL GEL RUGGIERO INNOVATIONS LLC _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._ ---------- RELIEVE & RELAX PAIN RELIEVING GEL DRUG FACTS ACTIVE INGREDIENTS (% BY WEIGHT) Camphor 4.0% Menthol 10.0% PURPOS E Topical Analgesic (pain relief) US ES : Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains, etc. WARNINGS : • For external use only. • Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or on mucous membranes. • If conditions worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days, discontinue use of this product and consult a doctor. DO NOT USE on wounds or damaged skin. Do not bandage tightly. KEEP OUT OF REACH OF CHILDREN. Use only as directed. If swallowed, get medical help or contact a poison control center right away. FLAMMABLE • keep away from fire or flame. Do not use if pregnant or breastfeeding. DIRECTIONS : SHAKE WELL BEFORE USE Adults and children 12 years of age and older: Using the roll-on applicator, massage a liberal amount of gel directly on the affected area not more than 3-4 times daily. Children under 12 years of age: Ask a doctor. OTHER INFORMATION: Protect this product from excessive heat or direct sun. Store away from children. INACTIVE INGREDIENTS: Acrylates/Beheneth-25 Methacrylate Copolymer,Caprylyl Glycol, Chondroitin Sulfate, Ethanol SDA 40B, Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Magnesium Chloride, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Triethanolamine, Water PACKAGE LABELING: RELIEVE AND RELAX PAIN RELIEVING menthol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:72155-0 0 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS Przeczytaj cały dokument