Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredients Capsaicin 0.25%
OTC - PURPOSE SECTION
Purpose External analgesic
DRUG FACTS
- Set ID
- 5145f124-268f-40d9-8fe5-1bb1ff7869c3
- Manufacturer
- DERSAN PHARMACEUTICAL CO LTD
- Effective date
- 2017-06-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:50:01
Key Label Information
Uses
INDICATIONS & USAGE SECTION
Uses Temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains
Warnings
WARNINGS SECTION
Warnings For external use only Allergy alert: This product contains natural rubber latex which may cause allergic reactions
OTC - DO NOT USE SECTION
Do not use on wounds on irritated or damaged skin
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Directions 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 Label Information
INACTIVE INGREDIENT SECTION
Inactive ingredients Beta-pinene homopolymer, calcium carbonate, light steam-cracked aromatic naphtha (petroleum), polybutenes, rubber (natural), synthetic iron oxide, and zinc oxide.
OTC - QUESTIONS SECTION
Questions or comments? (888) 221-3496 M-F 9 am to 5 pm you may also report serious side effects to this phone number
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED PLASTER NDC 11993-001-01 Simple backache, Arthritis, Strains, Bruises, Sprains 1 Sheet - 4.5 in x 7 in (11.4 cm x 17.8 cm)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED PLASTER NDC 11993-001-02 Simple backache, Arthritis, Strains, Bruises, Sprains 5 Sheets - (3.4 x 4.5 in Each)
Products
- ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| CAPSAICIN | S07O44R1ZM | ACTIB |
| .BETA.-PINENE | 4MS8VHZ1HJ | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| NAPHTHA | O3L624621X | IACT |
| POLYBUTENE (1400 MW) | 1NA5AO9GH7 | IACT |
| NATURAL LATEX RUBBER | 2LQ0UUW8IN | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| ZINC OXIDE | SOI2LOH54Z | IACT |
Complete SPL Sections
OTC - ACTIVE INGREDIENT SECTION
Active ingredients Capsaicin 0.25%
OTC - PURPOSE SECTION
Purpose External analgesic
INDICATIONS & USAGE SECTION
Uses Temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains
WARNINGS SECTION
Warnings For external use only Allergy alert: This product contains natural rubber latex which may cause allergic reactions
OTC - DO NOT USE SECTION
Do not use on wounds on irritated or damaged skin
OTC - WHEN USING SECTION
When using this product avoid contact with the eyes or mucous membranes do not bandage tightly
OTC - STOP USE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions 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
Other 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 SECTION
Inactive ingredients Beta-pinene homopolymer, calcium carbonate, light steam-cracked aromatic naphtha (petroleum), polybutenes, rubber (natural), synthetic iron oxide, and zinc oxide.
OTC - QUESTIONS SECTION
Questions or comments? (888) 221-3496 M-F 9 am to 5 pm you may also report serious side effects to this phone number
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED PLASTER NDC 11993-001-01 Simple backache, Arthritis, Strains, Bruises, Sprains 1 Sheet - 4.5 in x 7 in (11.4 cm x 17.8 cm)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED PLASTER NDC 11993-001-02 Simple backache, Arthritis, Strains, Bruises, Sprains 5 Sheets - (3.4 x 4.5 in Each)
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/5145f124-268f-40d9-8fe5-1bb1ff7869c3/dbc77d91-1795-45cb-95ee-f1dae0b20e9f.xml
- XML SHA-256
- c8216a6c0ab1b5493b32e83a6abf30d66de1d1bd0f1f7a64025c794dc48f90d7
- XML bytes
- 25492
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 1-sheet Pouch Fr_Bk.jpg | 2017-06-02 |
| otc | 5-sheet_Pouch.jpg | 2017-06-02 |
| otc | dbc77d91-1795-45cb-95ee-f1dae0b20e9f.xml | 2017-06-02 |