Label: SINSINPAS PAIN RELIEVING PATCH- dl-camphor, l-menthol, methyl salicylate patch
- NDC Code(s): 55264-101-01, 55264-101-02, 55264-101-03
- Packager: Sinsin 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 November 14, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
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Warnings
For external use only
Do not use- on wounds or damaged skin
- if you are allergic to any ingredients of this product
- with a heating pad
- with, or at the same time as, other external analgesic products
When using this product
- do not use otherwise than directed
- avoid contact with eyes, mucous membranes or rashes
- do not bandage tightly
Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates
Stop use and ask a doctor if
- rash, itching, or excessive skin irritation develops
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Inactive Ingredients
- SINSINPAS Pain Relieving Patch
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INGREDIENTS AND APPEARANCE
SINSINPAS PAIN RELIEVING PATCH
dl-camphor, l-menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5.56 g in 459.93 g LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 25.48 g in 459.93 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 28.1 g in 459.93 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ZINC OXIDE (UNII: SOI2LOH54Z) CALCIUM CARBONATE (UNII: H0G9379FGK) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) QUINONE (UNII: 3T006GV98U) GLYCERYL ABIETATE (UNII: 2F22LY70Q1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-101-03 2 in 1 PACKAGE 05/01/2017 1 NDC:55264-101-02 20 in 1 POUCH 1 NDC:55264-101-01 459.93 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 05/01/2017 Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161) Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143) Establishment Name Address ID/FEI Business Operations Sinsin Pharmaceutical Co., Ltd. 687867143 manufacture(55264-101)