CAPSAICIN HEAT- capsaicin patch 
Universal Distribution Center LLC

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Capsaicin Heat Patch

Drug Facts

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:

EXTERNAL USE ONLY

DO NOT USE
• on wounds or damaged skin
• with a heating pad
• with or at the same times as other external analgesic
• 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
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower

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 few days

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

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

Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin

Compare to the active ingredient in Salonpas® - Hot Capsicum Patch®

*This product is NOT manufactured or distributed by Hisamitsu®, owner of Salonpas® Hot Capsicum Patch.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

Made in P.R.C.

Packaging

HEATpatch-rev5

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
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
KAOLIN (UNII: 24H4NWX5CO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
WATER (UNII: 059QF0KO0R)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
TARTARIC ACID (UNII: W4888I119H)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
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 DrugM01703/07/2019
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIBusiness Operations
Koolcare Technology Co., Ltd.602479389manufacture(52000-040)

Revised: 6/2024
Document Id: d52ee697-8039-4375-81e0-e2bfd9445ea5
Set id: b3b40f77-3b0b-4111-968b-f3a87a5701fa
Version: 2
Effective Time: 20240605
 
Universal Distribution Center LLC