Label: CHO-A POINT PLASTER- methyl salicylate, l-menthol, dl-camphor patch
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Contains inactivated NDC Code(s)
NDC Code(s): 58354-104-01, 58354-104-02, 58354-104-03 - Packager: Cho-A Pharm.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 December 28, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Directions
- Inactive ingredients
- Keep out of reach of children
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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 5-6 days
- symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.
- Uses
- Cho-A Point Plaster
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INGREDIENTS AND APPEARANCE
CHO-A POINT PLASTER
methyl salicylate, l-menthol, dl-camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58354-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 1.108 mg in 67.15 mg LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 2.769 mg in 67.15 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 5.541 mg in 67.15 mg Inactive Ingredients Ingredient Name Strength NONIVAMIDE (UNII: S846B891OR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) MINERAL OIL (UNII: T5L8T28FGP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DIPHENHYDRAMINE (UNII: 8GTS82S83M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58354-104-03 2 in 1 BOX 12/28/2017 1 NDC:58354-104-02 60 in 1 POUCH 1 NDC:58354-104-01 67.15 mg 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 12/28/2017 Labeler - Cho-A Pharm.Co.,Ltd. (688056831) Registrant - Cho-A Pharm.Co.,Ltd. (688056831) Establishment Name Address ID/FEI Business Operations Cho-A Pharm.Co.,Ltd. 688056831 manufacture(58354-104)