STOPAIN COLD PROFESSIONAL STRENGTH 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 Professional Strength Pain Relieving Gel

Drug Facts

Active Ingredient

Menthol 8.0%

Purpose

Topical Analgesic

Uses: For the temporary relief of minor aches and pains of muscle and joints associated with - simple backache -arthritis - strains - bruises -sprains

Warnings

For external use only. Avoid contact with eyes.

Flammable: Keep away from fire or 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 symptoms persist for more than 7 days or clear up and occur again within a few days.
redness is present
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 as necessary, but do not apply more than 4 times daily.

Children 12 years or younger: ask a doctor.

Other information

Store at room temperature.

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, acrylate copolymer, Boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39-C, triethanolamine, water

Manufactured for: Troy Healthcare, LLC 130 Lions Drive, Hazleton, PA 18202

800-201-PAIN (7246)

www.stopain.com

NOTHING LASTS LONGER

PROFESSIONAL STRENGTH

STOPAIN COLD

PAIN RELIVING GEL

Immediate, Penetrating Pain Relief From:

Arthritis

Muscle Aches

Back Pain

Stopain. Exactly what it does.

Sweat resistant

Non-greasy

Easy to use

Pharmacist recommended

Our pharmacist recommended formulas:

Work on contact

Provide long-lasting pain relief

Does not contain aspirin, acetaminophen, dyes, fragrances or parabens

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

made in USA

To report a serious adverse event, contact (800) 201 PAIN (7246)

Stopain Cold Professional Strength Pain Relieving Gel

STOPAIN COLD PROFESSIONAL STRENGTH PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63936-8750
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	80 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63936-8750-1	3510 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/03/2014	12/21/2015
2	NDC:63936-8750-2	440 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/03/2014	12/21/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/03/2014	12/21/2015

Labeler - TROY MANUFACTURING, INC (160075248)

Registrant - TROY MANUFACTURING, INC (160075248)

Name	Address	ID/FEI	Business Operations
Establishment
TROY MANUFACTURING, INC		160075248	manufacture(63936-8750)

Revised: 12/2019

Document Id: 99820b99-64a3-998b-e053-2995a90a7fb5

Set id: 38e07171-9ec9-453c-ac01-ed8bf837a223

Version: 2

Effective Time: 20191212

TROY MANUFACTURING, INC