Pain Relief Hot Patch by Universal Distribution Center LLC / Beijing HKKY Medical Tech. Co., Ltd. Pain Relief Hot Patch

Pain Relief Hot Patch by

Drug Labeling and Warnings

Pain Relief Hot Patch by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Beijing HKKY Medical Tech. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN RELIEF HOT PATCH- menthol and 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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Pain Relief Hot Patch

Drug Facts

Active Ingredients

Menthol 30 mg

Capsaicin 8.3 mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pains associated with:

• arthritis simple backache bursitis  tendonitis muscle strains bruises cramps

WARNINGS:

EXTERNAL USE ONLY

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 do not apply to wounds or damaged skin.

STOP USE and ask a doctor if

condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days

redness is present skin irritation develops

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 older:

• Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
• Apply to affected area not more than 3 to 4 times a daily
  
  Children under 12 years of age: DO NOT use without consulting a doctor.

Inactive Ingredients

glycerin, sodium polyacrylate, aluminum glycinate, kaolin, methylparaben, propylparaben, alcohol, titanium dioxide, tartaric acid, sorbitan monooleate, polysorbate 80, purified water

EXTRA STRENGTH PAIN RELIEF HOT PATCH soothes and relieves pain associated with minor aches and pains. It is ideal for small areas such as arm, neck and leg.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard Edison, NJ 08817

Packaging

PAIN RELIEF HOT PATCH 
menthol and capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	30 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	8.3 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-034-42	1 in 1 BOX	06/21/2017	04/06/2020
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/21/2017	04/06/2020

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Universal Distribution Center LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd		420598724	manufacture(52000-034)

Revised: 4/2020

Document Id: 05d9a640-5aa2-42f1-a019-a906c07a80d4

34390-5

Set id: b291eb62-a68e-444c-b409-8b5a6e6d23d7

Version: 4

Effective Time: 20200410