STOPAIN EXTRA STRENGTH- 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 Extra Strength Gel

Drug Facts

Active Ingredient

Menthol 8.0%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • stains • 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 if 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 if necessary, but do not apply more than 4 times daily.

Children 12 years of younger: ask a doctor.

Other Information

• Store at room temperature

Inactive Ingredients

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).

Package Labeling:

Label0

STOPAIN EXTRA STRENGTH
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63936-8801
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
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PEPPERMINT OIL (UNII: AV092KU4JH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63936-8801-1	3 g in 1 PACKET; Type 0: Not a Combination Product	01/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/31/2023

Labeler - Troy Manufacturing, Inc. (160075248)

Name	Address	ID/FEI	Business Operations
Establishment
Troy Manufacturing, Inc.		160075248	manufacture(63936-8801)

Revised: 2/2023

Document Id: f4d41b65-93dc-c664-e053-2a95a90a5d2a

Set id: 07e9a235-6d10-4407-8729-beaf936e97ad

Version: 2

Effective Time: 20230216

Troy Manufacturing, Inc.