Label: FAMILY CARE THERA FLEX PAIN- capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide patch
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-100-10 - Packager: UNITED EXCHANGE CORP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 30, 2012
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ACTIVE INGREDIENT
Active ingredients (in each patch) Purpose
Capsaicin 0.0056%...............................................................................................................Topical analgesic
DL-Camphor 1.48%...............................................................................................................Topical analgesic
L-Menthol 3.95%...................................................................................................................Topical analgesic
Methyl salicylate 3.95%.........................................................................................................Topical analgesic
Peppermint oil 1.95%.............................................................................................................Skin protectant
Zinc oxide 18.77%.................................................................................................................Skin protectant
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY CARE THERA FLEX PAIN
capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0056 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 1.48 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.95 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 3.95 g PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL 1.95 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18.77 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CALCIUM CARBONATE (UNII: H0G9379FGK) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-100-10 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/30/2012 Labeler - UNITED EXCHANGE CORP (840130579)