STOPAIN COLD PAIN RELIEVING GEL

STOPAIN COLD PAIN RELIEVING by

Drug Labeling and Warnings

STOPAIN COLD PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by Troy Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOPAIN COLD PAIN RELIEVING- menthol gel 
Troy Manufacturing, Inc.

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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STOPAIN COLD PAIN RELIEVING GEL

Active Ingredient

Menthol 6.0%

Purpose

Topical Analgesic.

Uses

For the temporary relief of m inor aches and pains of muscles and joints associated with: simple backache,

arthritis

strains

bruises

sprains

Warnings

For external use only. Avoid contact with eyes.

Flammable: keep away from fire and flame

When using this product

use only as directed

 do not bandage tightly or use a heating pad.

do not apply to wounds or damaged skin.

Stop use and ask a doctor if

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

excessive irritation of the skin 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 right away.

Directions

Adults and children over 12 years

apply directly onto affected area without the need to bandage

repeat if necessary, but do not apply more than 4 times daily.

Children 12 years or younger: ask a doctor.

Other Information:

Store at room temperature

Close cap tightly after use.

Inactive Ingredients

Arnica montana flower extract, carbomer, propylene glycol, SD alcohol 39-C, silica, triethanolamine, water.

Manufactured for:

Troy Healthcare, LLC
130 Lions Drive

Hazelton, PA 18202

800-201-PAIN (7246)

www.stopain.com

made in USA

NOTHING LASTS LONGER

New!

STOPAIN COLD

Pain Relieving Gel

Menthol 6%

Fast Acting

Long-Lasting

Immediate, Penetrating pain relief from

Arthritis

Muscle Aches

Back Pain

Stopain Cold

Stopain. Exactly what it does. TM

Fast acting

Long Lasting

Light, pleasant scent

Non-greasy

Non-staining

Works on contact

Pharmacist recommended

Your purchase benefits the Arthritis Foundation

For every unit of Stopain product sold, Troy Healthcare, LLC will donate a portion of the proceeds to the Arthritis Foundation with a minimum contribution of $25,000 to help people take control of arthritis. For informaiton about arthritis, contact the Foundation at 800.283-7800 or www.arthritis.org

Our pharmacist Recommended formulas

Work on contact

Provide long-lasting pain relief

For more information, visit www.stopain.com today.

Package Principal Display

Drug Facts Panel

Product Carton Label

STOPAIN COLD PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63936-8582
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63936-8582-1	1 in 1 BOX	12/03/2010	12/31/2012
1		70.8 g in 1 TUBE; 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	12/03/2010	12/31/2012

Labeler - Troy Manufacturing, Inc. (160075248)

Revised: 12/2019

Document Id: 99820b99-64db-998b-e053-2995a90a7fb5

34390-5

Set id: 80038a7a-723d-450a-aa53-0cae81277b04

Version: 8

Effective Time: 20191212

 

Troy Manufacturing, Inc.