ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED- 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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DRUG FACTS

Active ingredients
Capsaicin 0.25%

Purpose
External analgesic

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

Warnings
For external use only

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

Do not use

When using this product

Stop use and ask a 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? (888) 221-3496 M-F 9 am to 5 pm

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 Pouch

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 Pouch

ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED 
capsaicin plaster
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11993-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN70 mg
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11993-001-0124 in 1 BOX05/01/2007
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:11993-001-0210 in 1 BOX05/01/2007
25 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2007
Labeler - DERSAN PHARMACEUTICAL CO LTD (657669362)
Establishment
NameAddressID/FEIBusiness Operations
DERSAN PHARMACEUTICAL CO LTD657669362manufacture(11993-001)

Revised: 6/2017
Document Id: dbc77d91-1795-45cb-95ee-f1dae0b20e9f
Set id: 5145f124-268f-40d9-8fe5-1bb1ff7869c3
Version: 2
Effective Time: 20170601
 
DERSAN PHARMACEUTICAL CO LTD