MEDICATED PAIN RELIEF PATCHES- camphor, menthol, methyl salicylate patch

Medicated Pain Relief Patches by

Drug Labeling and Warnings

Medicated Pain Relief Patches by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association), Foshan Aqua Gel Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients Purpose

Camphor 3.1% ......................Topical Analgesic

Menthol 6.0% .......................Topical Analgesic

Methyl Salicylate 10.0% .......Topical Analgesic

For External Use Only

Allergy alert: If prone to allergic reaction from asprin or salicylates, consult a doctor before use

Do not use:

• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product

When using this product

• Use only as directed
• Avoid contact with eyes, mucous membranes or rashes
• Do not bandage tighly
• Do not use at the same time as other topical analgesics
• Dispose of used patch in manner that keeps product away from childrens and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor

• If rash, itching or excessive skin irritation develops
• If condition worsens
• if symptoms last more than 7 days or clear up and occur again with a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply 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 physician.

Inactive Ingredients

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication and Usage

For temporary relief of minor aches and pains.

Questions or Comments

Customer Care Help Line
248-449-9300
www.qualitychoice.com

Pain Relief Patch Label

Other Information: Store in clean, dy place outside of direct sunlight. Protect from excessive moisture.

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48375

Made in China

INGREDIENTS AND APPEARANCE

MEDICATED PAIN RELIEF PATCHES 
camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)

Product Characteristics
Color		Score
Shape	SQUARE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-124-60	60 in 1 BOX	09/01/2017
1		9 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 63868-124-20	20 in 1 BOX	09/01/2017
2		9 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	09/01/2017

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(63868-124)