Capsaicin Patch

Drug Labeling and Warnings

Drug Details [pdf]

CAPSAICIN- capsaicin patch 
Pharmaplast SAE

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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Capsaicin Patch

Drug Facts

Active ingredient

Capsicum extract 0.025% as Capsaicin

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

  • For external use only
  • Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower
  • Allergy alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use

If pregnant or breastfeeding

consult a healthcare professional before use.

Do not use

  • on wounds or damaged skin
  • with or at the same time as other external analgesic products

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes or rashes

Stop use and ask a doctor if

  • conditions worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days
  • rash, itching or excessive skin irritation develops

Keep out of reach of children.

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

Directions

adults and children 12 years of age and older

  • clean and dry affected area
  • remove patch from film
  • apply to affected area no more than 3 to 4 times daily for 7 days
  • remove patch from the skin after at most 8 hours application

children under 12 years of age consult a doctor

Other information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive ingredients

Zinc Oxide, Lanolin, 2,5-DI-TERT-PENTYLHYDROQUINONE, Natural Rubber, METHYL HYDROGENATED ROSINATE

PRINCIPAL DISPLAY PANEL

Pharmaplast Capsaicin patch
1 Pieces
Size 12x18 cm

PRINCIPAL DISPLAY PANEL Pharmaplast Capsaicin patch 1 Pieces Size 12x18 cm

CAPSAICIN 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 28691-0025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.6 mg
Inactive Ingredients
Ingredient NameStrength
ZINC OXIDE (UNII: SOI2LOH54Z)  
LANOLIN (UNII: 7EV65EAW6H)  
2,5-DI-TERT-PENTYLHYDROQUINONE (UNII: 19O4J76TTK)  
CAPSICUM OLEORESIN (UNII: UW86K581WY)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 28691-0025-11 in 1 CONTAINER; Type 0: Not a Combination Product01/11/201407/24/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/11/201407/24/2019
Labeler - Pharmaplast SAE (557735337)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaplast SAE557735337manufacture(28691-0025)

Revised: 7/2019
Document Id: 9a7cd6c0-12ce-49e3-81ba-b8d7366fdb3d
Set id: 31a192ea-ed62-430d-837a-880b06a00794
Version: 3
Effective Time: 20190724
 
Pharmaplast SAE