Label: ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED- capsaicin plaster
- NDC Code(s): 11993-001-01, 11993-001-02
- 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 June 1, 2017
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- WHEN USING
Stop use and ask a doctor if
- excessive irritation of the skin develops
- condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- when using for pain of arthritis:
- if pain persists for more than 10 days
- if redness is present
- in conditions affecting children under 12 years of age
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
- Peel apart from paper backing and apply directly to the affected area. If needed, cut plaster into small pieces and apply to affected area. It will be more effective when used after a bath.
- Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily.
- Children under 2 years: Do not use, consult a doctor.
OTHER SAFETY INFORMATION
- Not recommended for people with sensitive skin. May cause rash or festering.
- Not recommended for use when in contact with hot water. Burning sensation may occur.
- Do not apply on extremely hairy surface of skin. Highly adhesive plaster may hurt skin upon removal of product.
- Preserve in tight container after opening.
- Store at 20-25°C (68-77°F)
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11993-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 70 mg 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) FERRIC OXIDE RED (UNII: 1K09F3G675) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11993-001-01 24 in 1 BOX 05/01/2007 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:11993-001-02 10 in 1 BOX 05/01/2007 2 5 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 05/01/2007 Labeler - DERSAN PHARMACEUTICAL CO LTD (657669362) Establishment Name Address ID/FEI Business Operations DERSAN PHARMACEUTICAL CO LTD 657669362 manufacture(11993-001)