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NDC 63868-0124-60 Medicated Pain Relief Patches 3.1; 6; 10 g/100g; g/100g; g/100g Details

Medicated Pain Relief Patches 3.1; 6; 10 g/100g; g/100g; g/100g

Medicated Pain Relief Patches is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE.

Product Information

NDC	63868-0124
Product ID	63868-124_1289a099-6246-435f-8545-7084a73600e0
Associated GPIs	90809903255935
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Medicated Pain Relief Patches
Proprietary Name Suffix	n/a
Non-Proprietary Name	CAMPHOR, MENTHOL, METHYL SALICYLATE
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	3.1; 6; 10
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0124-60 (63868012460)

Pricing Information	N/A
NDC Package Code	63868-124-60
Billing NDC	63868012460
Package	60 PATCH in 1 BOX (63868-124-60) / 9 g in 1 PATCH
Marketing Start Date	2017-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 08bf26f5-8fbd-44b9-9f79-5044ba71eb70 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/01/2017

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

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

Revised: 9/2017

Document Id: 1289a099-6246-435f-8545-7084a73600e0

Set id: 08bf26f5-8fbd-44b9-9f79-5044ba71eb70

Version: 2

Effective Time: 20170914