NDC | 46581-890-01, 46581-890-03, 46581-890-99 |
Set ID | dd2325ae-ec41-4201-82af-0415cbccd880 |
Category | HUMAN OTC DRUG LABEL |
Packager | Hisamitsu Pharmaceutical Co., Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
Do not use
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
When using this product
- do not use otherwise than as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- discontinue use at least 1 hour before a bath or shower
- do not use immediately after a bath or shower
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Directions
Adults and children 12 years of age and over:
- clean and dry affected area
- remove film from patch and apply to the skin (see illustration)
- apply to affected area not more than 3 to 4 times daily
- remove patch from the skin after at most 8 hours' application
Children under 12 years of age: consult a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SALONPAS PAIN RELIEVING HOT-L
capsaicin, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46581-890 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSAICIN 0.025 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g in 100 g Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) POLYVINYL ALCOHOL (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM SILICATE (UNII: T1FAD4SS2M) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) GLYCERIN (UNII: PDC6A3C0OX) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) OLEYL ALCOHOL (UNII: 172F2WN8DV) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46581-890-03 1 in 1 BOX 1 3 in 1 POUCH 1 20 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:46581-890-01 1 in 1 POUCH 2 20 g in 1 PATCH; Type 0: Not a Combination Product 3 NDC:46581-890-99 1 in 1 POUCH 3 20 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 not final part348 05/01/2011 Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)