Label: TOPLAST COOL AND HOT MENTHOL 1.25PERCENT PLUS CAPSAICIN 0.025PERCENT- menthol, capsaicin patch
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Contains inactivated NDC Code(s)
NDC Code(s): 73279-0016-1, 73279-0016-2 - Packager: Icure Pharmaceutical Inc, Wanju Factory
- 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 July 28, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTS
- PURPOSE
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WARNINGS
For external use only
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Do not use
■ On wounds or damaged skin
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Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients
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When using this product
■ Use only as directed ■ Read and follow all directions and warnings on this label ■ Do not allow contact with the eyes and mucous membranes or rashes ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Discontinue use at least 1 hour before a bath or shower ■ Do not use immediately after a bath or shower
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Stop use and ask a doctor if
■ Condition worsens ■ Rash, itching or excessive skin irritation develops ■ Symptoms persist for more than 7 days or reoccur within a few days interval
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If pregnant or breast-feeding, ask a health professional before use - Keep out of reach of children and pets
- Uses
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Directions
Adult and children 12 years of age and over :
■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Apply to affected area not more than 3 to 4 times daily ■ Suggested duration of use for patch is upto 8 hours
Children under 12 years of age : Consult a physician - Other Information
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPLAST COOL AND HOT MENTHOL 1.25PERCENT PLUS CAPSAICIN 0.025PERCENT
menthol, capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73279-0016 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 Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Gelatin (UNII: 2G86QN327L) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) Kaolin (UNII: 24H4NWX5CO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Tartaric Acid (UNII: W4888I119H) EDETATE DISODIUM (UNII: 7FLD91C86K) Polysorbate 80 (UNII: 6OZP39ZG8H) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) Dihydroxyaluminum Aminoacetate (UNII: DO250MG0W6) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73279-0016-2 2 in 1 CARTON 07/01/2020 1 NDC:73279-0016-1 5 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2020 Labeler - Icure Pharmaceutical Inc, Wanju Factory (695687612) Registrant - Icure Pharmaceutical Inc, Wanju Factory (695687612) Establishment Name Address ID/FEI Business Operations Icure Pharmaceutical Inc, Wanju Factory 695687612 manufacture(73279-0016)
