Label: TEROCIN- methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion
- NDC Code(s): 50488-1231-1
- Packager: Alexso 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
Methyl Salicylate 25%
Temporarily relieves mild aches and pains of muscles or joints.Close
- 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.
- Keep out of reach of children.
Consult physician for children under 12.Close
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.Close
- 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,
Methylparaben, Propylparaben, DMDM Hydantoin, Iodopropynyl Butylcarbamate.Close
- Package/Label Principal Display Panel
120 ml (4 fl oz.)
Manufactured for: Alexso Inc.
Thousand Oaks, CA 91360
Made in U.S.A.
- INGREDIENTS AND APPEARANCE
methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50488-1231 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 25 g in 100 mL CAPSAICIN (CAPSAICIN) CAPSAICIN 0.025 g in 100 mL MENTHOL (MENTHOL) MENTHOL 10 g in 100 mL LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER PROPYLENE GLYCOL CETYL ALCOHOL STEARIC ACID GLYCERYL MONOSTEARATE POLYOXYL 100 STEARATE DIMETHYL SULFONE ALOE VERA LEAF BORAGE OIL INDIAN FRANKINCENSE XANTHAN GUM TROLAMINE METHYLPARABEN PROPYLPARABEN DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50488-1231-1 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2010 Labeler - Alexso Inc. (963338061)