PAIN RELIEF HOT PATCH- menthol and capsaicin 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, Koolcare Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each gram)

Menthol 30 mg

Capsaicin 0.83 mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain 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.

Other information

store at room temperature 68° to 77°F (20 to 25°C)

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

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.

FAST-ACTING PAIN RELIEF

Distributed by:

Universal Distribution Center

96 Distribution Boulevard Edison, NJ 08817

Packaging

INGREDIENTS AND APPEARANCE

PAIN RELIEF HOT PATCH 
menthol and capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-046
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  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.83 mg  in 1 g

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: 52000-046-42	1 in 1 BOX	03/23/2020
1		2 in 1 POUCH
1		0.206 g in 1 PATCH; 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	03/23/2020

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(52000-046)