Label: MENTHOZEN HYDROGEL- menthol, capsaicin patch
- NDC Code(s): 71205-334-05, 71205-334-15, 71205-334-30
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 71574-601
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 1, 2023
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- DRUG FACTS:
- ACTIVE INGREDIENTS:
- USES:
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WARNINGS:
For external use only. Use only as directed.
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- Avoid contact with eyes and mucous membranes.
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- Do not apply to open wounds or damaged skin.
Do not use
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- in combination with any external heat source.
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- Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
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DIRECTIONS:
Adults and children 12-years and over: Apply to affected area; change patch 1-2 times dily.
Children under 12, consult a physician before use.
How to Apply:
Remove patch from backing and apply directly to area of pain.
Do not apply to affected area more than three times daily.
Use only one patch at a time.
Wash hands with soap and water immediately after application.
Reseal pouch containg unused patches.
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
MENTHOZEN HYDROGEL
menthol, capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-334(NDC:71574-601) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 40 mg in 1 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.3 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) POLYSORBATE 80 (UNII: 6OZP39ZG8H) LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-334-05 5 in 1 POUCH 11/20/2020 1 1 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:71205-334-15 15 in 1 POUCH 09/01/2019 2 1 g in 1 PATCH; Type 0: Not a Combination Product 3 NDC:71205-334-30 30 in 1 POUCH 09/01/2019 3 1 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 07/01/2019 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-334) , RELABEL(71205-334)