Country: United States
Language: English
Source: NLM (National Library of Medicine)
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Preferred Pharmaceuticals, Inc.
TOPICAL
OTC DRUG
Topical Analgesic Temporarily relieves mild aches and pains of muscles or joints.
OTC monograph not final
TEROCIN- METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE LOTION PREFERRED PHARMACEUTICALS, INC. _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._ ---------- TEROCIN TOPICAL PAIN RELIEF LOTION ACTIVE INGREDIENT Methyl Salicylate 25% Capsaicin 0.025% Menthol 10% Lidocaine 2.50% PURPOS E Topical Analgesic US ES Temporarily relieves mild aches and pains of muscles or joints. WARNINGS • • • • KEEP OUT OF REACH OF CHILDREN. Consult physician for children under 12. DIRECTIONS Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately afterwards to avoid contact with eyes. INACTIVE INGREDIENTS Water (Aqua), Propylene Glycol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Dimethyl Sulfone, Aloe Barbadensis Leaf Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Xanthan Gum, Triethanolamine, Only for external use. DO NOT USE: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes. CONSULT YOUR PHYSICIAN: if pain is persistent or worsens or if using any other topical pain products. Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water. Methylparaben, Propylparaben, DMDM Hydantoin, Iodopropynyl Butylcarbamate. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 68788-9496-1 Terocin (terodoloricin) Topical Pain Relief Lotion Long Lasting Soothing Effect 120 ml (4 fl oz.) Manufactured for: Alexso Inc. Thousand Oaks, CA 91360 Made in U.S.A. Patent Pending PACKAG E LABEL TEROCIN methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 8 78 8 -9 49 6 (NDC:50 48 8 -1231) ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDI Read the complete document