Label: SATOHAP COOL AND HOT PADS- camphor, capsaicin, menthol patch
- NDC Code(s): 49873-621-01
- Packager: Sato Pharmaceutical Co., Ltd.
- 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 January 1, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- avoid contact with the eyes or mucus membranes
- do not bandage tightly
- do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
Stop use and ask a doctor if
- condition worsens
- symptoms persists for more than 7 days
- symptoms clear up and occur again within a few days
- excessive irritation of the skin developes
- nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs.
- you feel actual pain or experience a blistering or burning after application (it is normal to feel awarming or cooling sensation)
- when using for pain or arthritis:
- pain persists for more than 10 days
- redness is present
- in conditions affecting children under 12 years of age
- Directions
- Other information
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Inactive ingredients
carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, dried aluminum hydroxide gel, edetate disodium, emulsion of methyl acrylate and 2-ethylhexyl acrylate copolymer, glycerin, malic acid, partially neutralized polyacrylate, polysorbate 80, polyvinyl alcohol, sorbitol solution, talc, titanium dioxide, and water on a polyester fiber backing and covered with a polyethylene film.
- Questions or comments?
- Satohap Cool and Hot Pads
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INGREDIENTS AND APPEARANCE
SATOHAP COOL AND HOT PADS
camphor, capsaicin, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-621 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.04 g in 100 mL LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 6 g in 100 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3.1 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) WATER (UNII: 059QF0KO0R) METHYL ACRYLATE (UNII: WC487PR91H) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) GLYCERIN (UNII: PDC6A3C0OX) TALC (UNII: 7SEV7J4R1U) EDETATE DISODIUM (UNII: 7FLD91C86K) MALIC ACID (UNII: 817L1N4CKP) TRIETHYLENE GLYCOLDIMETHACRYLATE (UNII: 14I47YJ5EY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49873-621-01 1 in 1 BOX 12/18/2020 1 5 mL 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 12/18/2020 Labeler - Sato Pharmaceutical Co., Ltd. (690575642) Establishment Name Address ID/FEI Business Operations Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-621) , pack(49873-621) , label(49873-621) Establishment Name Address ID/FEI Business Operations Fuji Seal, Inc. 718023935 pack(49873-621) , label(49873-621)