ASTRAPHARM CHILLI BRAND- capsaicin plaster

ASTRAPHARM CHILLI BRAND by

Drug Labeling and Warnings

ASTRAPHARM CHILLI BRAND by is a Otc medication manufactured, distributed, or labeled by Dersan Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Capsaicin 0.25%..............................External analgesic

ASK DOCTOR

Stop use and ask doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• 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:

• Once opened, keep the unused plaster in an air-tight container.
• Store at 20-25°C(68-77°F)

Inactive ingredients:

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

Questions or comments?

M-F, 9 am to 5 pm Pacific Time

• You may also report serious side effects to this phone number.

Purpose

External analgesic

Do not use

• on wounds
• damaged or irritated skin

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

• 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 redness is present
•    in conditions affecting children under 12 years of age  

Uses:

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

Astrapharm "Chilli Brand" External Analgesic Plaster 4.5in x 7in

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Inner Package 4.5in x 7in

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Astrapharm "Chilli Brand" External Analgesic Plaster 4.5in x 3.4in

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Inner Package 4.5in x 3.5in

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INGREDIENTS AND APPEARANCE

ASTRAPHARM CHILLI BRAND 
capsaicin plaster

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)