FDA.reportPublic FDA data

ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED

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

Label at a glance#

ProductASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED
Active ingredientCAPSAICIN
Label structure14 sections

Label contents#

Full prescribing information#

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)

1 Sheet Pouch1 Sheet Pouch

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)

5 Sheet Pouch5 Sheet Pouch

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11993-001-012025-01-30C16284748780-1c7ccaba7-27ae-fd44-e053-dadaa90aa01bDRUG FACTS
11993-001-022025-01-30C16284748780-1c7ccaba7-27ae-fd44-e053-dadaa90aa01bDRUG FACTS
11993-001-012021-09-17C16284748780-1c7ccaba7-27ae-fd44-e053-dadaa90aa01bDRUG FACTS
11993-001-022021-09-17C16284748780-1c7ccaba7-27ae-fd44-e053-dadaa90aa01bDRUG FACTS
11993-001-012021-07-23C16284748780-1c7ccaba7-27ae-fd44-e053-dadaa90aa01bDRUG FACTS
11993-001-022021-07-23C16284748780-1c7ccaba7-27ae-fd44-e053-dadaa90aa01bDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11993-001-01ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED24 in 1 BOXPLASTER242
11993-001-01ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED1 in 1 POUCHPLASTER12
11993-001-02ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED5 in 1 POUCHPLASTER52
11993-001-02ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED10 in 1 BOXPLASTER102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11993-001ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED (CAPSAICIN) PLASTER [DERSAN PHARMACEUTICAL CO LTD]2Legacy NDC, 4 package rows20170602_5145f124-268f-40d9-8fe5-1bb1ff7869c3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11993-00111993-001-01, 11993-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
.BETA.-PINENE4MS8VHZ1HJIACT
CALCIUM CARBONATEH0G9379FGKIACT
NAPHTHAO3L624621XIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
NATURAL LATEX RUBBER2LQ0UUW8INIACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dbc77d91-1795-45cb-95ee-f1dae0b20e9f5145f124-268f-40d9-8fe5-1bb1ff7869c32017-06-01WarningsExact identifier
spl id: dbc77d91-1795-45cb-95ee-f1dae0b20e9f
spl set id: 5145f124-268f-40d9-8fe5-1bb1ff7869c3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.