Label: LABOFLEX COOL AND HOT MENTHOL 1.25 PERCENT CAPSAICIN 0.025 PERCENT- menthol, capsaicin patch
- NDC Code(s): 83655-103-11, 83655-103-12
- Packager: Laboflex, Inc.
- 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 8, 2023
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- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTS
- PURPOSE
- WARNINGS
- Keep out of reach of children
- Uses
- Directions
- Other Information
- Questions or Comments
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LABOFLEX COOL AND HOT MENTHOL 1.25 PERCENT CAPSAICIN 0.025 PERCENT
menthol, capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83655-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 87.5 mg CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 1.75 mg Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) POVIDONE K90 (UNII: RDH86HJV5Z) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TARTARIC ACID (UNII: W4888I119H) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) KAOLIN (UNII: 24H4NWX5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83655-103-11 2 in 1 CARTON 08/28/2023 1 5 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:83655-103-12 5 in 1 POUCH; Type 0: Not a Combination Product 08/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/28/2023 Labeler - Laboflex, Inc. (128394050) Registrant - Laboflex, Inc. (128394050) Establishment Name Address ID/FEI Business Operations WOOSHIN LAPACHE d.o.o. 507385209 manufacture(83655-103)