ASTRAPHARM CHILLI BRAND- capsaicin plaster 
Dersan Pharmaceutical Co., Ltd

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.

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ASTRAPHARM CHILLI BRAND EXTERNAL ANALGESIC PLASTER

Active ingredients

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

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:

Other information:

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

Purpose

External analgesic

Do not use

When using this product

Stop use and ask a doctor if

Uses:

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

Warnings

For external use only

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

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Astrapharm Chilli Brand PDP

Inner Package 4.5in x 7in

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Inner Package

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

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Astrapharm Chilli Brand PDP

Inner Package 4.5in x 3.5in

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image description

ASTRAPHARM CHILLI BRAND 
capsaicin plaster
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11993-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11993-000-0124 in 1 PACKAGE03/01/2020
1NDC:11993-000-110.25 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:11993-000-0250 in 1 PACKAGE03/01/2020
2NDC:11993-000-125 in 1 PACKAGE
20.25 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2020
Labeler - Dersan Pharmaceutical Co., Ltd (657669362)

Revised: 7/2020
Document Id: aa6d0e93-e3ac-ba03-e053-2a95a90ab8fa
Set id: b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec
Version: 2
Effective Time: 20200714
 
Dersan Pharmaceutical Co., Ltd