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:

Warnings

External use only.

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Adults and Children 12 years of age and over:

Children under 12 years of age: Consult a doctor.

Other information

Inactive Ingredients

lanolin, methyl salicylate, natural latex rubber, peppermint oil, petrolatum, rosin, zinc oxide

PRINCIPAL DISPLAY PANEL

Capsaicin Heat Patch

label

CAPSAICIN HEAT 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PETROLATUM (UNII: 4T6H12BN9U)  
ROSIN (UNII: 88S87KL877)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-040-411 in 1 BOX03/07/2019
1NDC:52000-040-402 in 1 POUCH
13.28 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 finalpart34803/07/2019
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(52000-040)

Revised: 3/2019
Document Id: 81ddb992-34a9-1e1b-e053-2a91aa0a8159
Set id: b3b40f77-3b0b-4111-968b-f3a87a5701fa
Version: 1
Effective Time: 20190307
 
Universal Distribution Center LLC