STOPAIN EXTRA STRENGTH GEL- menthol gel

Stopain Extra Strength Gel by

Drug Labeling and Warnings

Stopain Extra Strength Gel by is a Otc medication manufactured, distributed, or labeled by Troy Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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  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 if symptoms persist for more than 7 days or clear up and occur again wihin 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 or 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:63936-8800-3

Package Labeling:63936-8800-2

Package Labeling:63936-8800-1

Package Labeling:63936-8800-4

INGREDIENTS AND APPEARANCE

STOPAIN EXTRA STRENGTH GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63936-8800
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63936-8800-3	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2022
2	NDC: 63936-8800-2	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2022
3	NDC: 63936-8800-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2022
4	NDC: 63936-8800-4	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/10/2022

Labeler - Troy Manufacturing, Inc. (160075248)