Drug Details [pdf]

PAIN RELIEVING PATCH- menthol patch
Essentials Biotech Co, Ltd

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.

----------

Active Ingredients Purpose

Menthol 5% .......................Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to

arthritis
simple backache
strains
sprains
bruises

Warnings

For external use only

Do not use

on wounds or damaged skin
if you are allergic to any ingredients of this product
with a heating pad

When using this product

use only as directed
do not bandage tightly
avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if

excessive redness or irritation is present
conditions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a 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 right away.

Directions

Adults and children 12 years of age and over:

clean and dry affected area
remove film from patch and apply to the skin
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Other information

Avoid storing product in direct sunlight
Protect product from excessive moisture

Glycerin, Sodium polyacrylate, Aluminum Hydroxide, Disodium EDTA, Titanium Dioxide, Water, Tartaric Acid, Polyvinyl alcohol, Caster oil, Polysorbate, Isopropyl myristate, Kaolin

Manufactured by:

Essentials Biotech Co., Ltd.

Address: No.8 Plant, No. 26 Qinghua Rd, Xuguan

Industrial Zone, Suzhou, Jiangsu 21515, China (CHN)

121801

PAIN RELIEVING PATCH
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71183-112
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
CASTOR OIL (UNII: D5340Y2I9G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Product Characteristics
Color		Score
Shape	SQUARE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 71183-112-02	5 in 1 BOX	07/20/2018	03/01/2019
1		0.05 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/20/2018	03/01/2019

Labeler - Essentials Biotech Co, Ltd (544530742)

Registrant - Essentials Biotech Co, Ltd (544530742)

Revised: 11/2019

Document Id: 968b694f-2729-29eb-e053-2995a90a8e03

Set id: 717744fd-bea0-e82a-e053-2995a90a98b1

Version: 2

Effective Time: 20191104

Drug Labeling and Warnings

Drug Details [pdf]