ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED- capsaicin plaster

ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED by

Drug Labeling and Warnings

ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED by is a Otc medication manufactured, distributed, or labeled by DERSAN PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Capsaicin 0.25%

PURPOSE

Purpose
External analgesic

INDICATIONS & USAGE

Uses Temporarily relieves minor aches and pains of muscles and joints due to:

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings
For external use only

Allergy alert: This product contains natural rubber latex which may cause allergic reactions

DO NOT USE

Do not use

• on wounds
• on irritated or damaged skin

WHEN USING

When using this product

• avoid contact with the eyes or mucous membranes
• do not bandage tightly

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

Inactive ingredients Beta-pinene homopolymer, calcium carbonate, light steam-cracked aromatic naphtha (petroleum), polybutenes, rubber (natural), synthetic iron oxide, and zinc oxide.

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

• you may also report serious side effects to this phone number

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)

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)

INGREDIENTS AND APPEARANCE

ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED 
capsaicin plaster

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)