Label: ASTRAPHARM CHILLI BRAND- capsaicin plaster
- NDC Code(s): 11993-000-01, 11993-000-02, 11993-000-11, 11993-000-12
- Packager: Dersan 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.
Updated July 14, 2020
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- Active ingredients
- ASK DOCTOR
- Keep out of reach of children
- Clean and dry affected area, peel plaster away from paper backing and apply to the affected area by pressing edges down firmly.
- If needed, cut plaster into smaller pieces.
- Adults and children 12 years of age and over: Apply to affected area not more than 3 times daily. Children under 12 years, consult doctor before use.
- Other information:
- Inactive ingredients:
- Questions or comments?
- Do not use
When using this product
- avoid contact with the eyes or mucous membranes
- do not bandage tightly
- may cause rash or festering. Not recommended for people with sensitive skin.
- burning sensation may occur. Not recommended for use when in contact with hot water.
- highly adhesive plaster may hurt skin upon removal of product. Do not apply on hairy surface of skin.
- Stop use and ask a doctor if
- Astrapharm "Chilli Brand" External Analgesic Plaster 4.5in x 7in
INGREDIENTS AND APPEARANCE
ASTRAPHARM CHILLI BRAND
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11993-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength .BETA.-PINENE (UNII: 4MS8VHZ1HJ) CALCIUM CARBONATE (UNII: H0G9379FGK) NAPHTHA (UNII: O3L624621X) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) BROWN IRON OXIDE (UNII: 1N032N7MFO) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11993-000-01 24 in 1 PACKAGE 03/01/2020 1 NDC:11993-000-11 0.25 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:11993-000-02 50 in 1 PACKAGE 03/01/2020 2 NDC:11993-000-12 5 in 1 PACKAGE 2 0.25 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 03/01/2020 Labeler - Dersan Pharmaceutical Co., Ltd (657669362)