Capsaicin Heat Patch

Capsaicin Heat Patch

Drug Labeling and Warnings

Drug Details

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CAPSAICIN HEAT- capsaicin patch 
Universal Distribution Center LLC

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 Heat Patch

Active Ingredient

Capsicum Extract Capsaicin 0.025%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles & joints associated with:

  • Simple Backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

For external use only.
Discontinue use at least one hour before a shower or bath and do not use immediately after a shower or bath.

Do not use

  • on wounds or damaged skin.
  • with a heating pad.
  • with, or at the same times as, other external analgesic products.
  • if you are allergic to any ingredients of this product.

When using this product

  • do not use otherwise than as directed.
  • avoid contact with the eyes, mucous membranes or rashes.

Stop use and ask a doctor if

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

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 over:

  • Clean and dry affected area.
  • Remove patch from film.
  • Apply to affected area not 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 physician.

Other information

  • Avoid storing product in direct sunlight.
  • Protect product from excessive moisture.

Inactive Ingredients

belladonna extract, camphor, diphenhydramine, lanolin, peppermint oil, rubber, vaseline, methyl salicylate, polyster resin, zinc oxide.

PRINCIPAL DISPLAY PANEL

Capsaicin Heat Patch

label

CAPSAICIN HEAT 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52000-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.6 mg
Inactive Ingredients
Ingredient NameStrength
BELLADONNA LEAF (UNII: 6GZW20TIOI)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
DIPHENHYDRAMINE (UNII: 8GTS82S83M)  
LANOLIN (UNII: 7EV65EAW6H)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52000-031-411 in 1 BOX06/20/2017
1NDC: 52000-031-402 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/20/2017
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIBusiness Operations
Beijing HKKY Medical Tech. Co., Ltd.544434817manufacture(52000-031)

Revised: 6/2017
 
Universal Distribution Center LLC


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