Country: United States
Language: English
Source: NLM (National Library of Medicine)
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
Nature City, LLC
TOPICAL
OTC DRUG
Topical analgesic For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps. - DO NOT USE A HEATING PAD.
OTC monograph not final
TRUE PAIN RELIEF PLUS- METHYL SALICYLATE, MENTHOL, CAPSAICIN LOTION NATURE CITY, 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._ ---------- TRUE PAIN RELIEF PLUS ACTIVE INGREDIENTS: Methyl Salicylate 10.00% Menthol 1.25% Capsaicin 0.025% PURPOSE Topical analgesic USES: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps. WARNINGS: For external use only. Avoid getting into the eyes or on mucous membranes. Do not apply to irritated skin and discontinue use if excessive irritation develops. If pain persists for more than 7 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately. Do not expose treated area to heat or direct sunlight. Do not bandage. Do not apply to wounds or damaged skin. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. DO NOT USE A HEATING PAD. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN In case of accidental ingrestion, seek professional assistance or contact a poison control center immediately. DIRECTIONS: ADULTS: Apply liberally to affected area not more than 3 to 4 times daily. WASH HANDS WITH SOAP AND WATRE AFTER APPLYING. For optimum relief, continue to apply every day, 3 to 4 times daily. Children under 12 years of age, consult a doctor. INACTIVE INGREDIENTS: Water, Aloe Barbadensis Leaf Extract, Cetyl Alcohol, PEG-8, Isopropyl Myristate, Camphor, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Disodium EDTA, Methylisothiazolinone, Triethanolamine. TRUE PAIN RELIEF PLUS methyl salicylate, menthol, capsaicin lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:69180-001 ROUTE OF ADMINISTRATION TOPICAL ACTI Read the complete document