stopain extra strength gel

stopain extra strength gel
SPL v2
SPL
SPL Set ID 8bb89002-d7a2-4bee-b5a5-1fd1949273ef
Route
topical
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (80 mg)
Inactive Ingredients
dimethyl sulfone eucalyptus oil glucosamine sulfate hydroxypropyl cellulose, unspecified peg-8 dimethicone (600 cst) pentylene glycol peppermint oil trolamine water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-15

Purpose

Topical Analgesic

Description

Menthol 8.0%


Medication Information

Warnings

For external use only.Avoid contact with eyes.

Flammable: Keep away from fire or flame.

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Purpose

Topical Analgesic

Directions

Adults and children 2 years of age and older: • apply directly onto affected area, not more than 3 to 4 times daily • wash hands after use

Children under 2 years of age:do not use, consult a doctor

Other Information

Store at room temperatur

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) 

Description

Menthol 8.0%

Active Ingredient

Menthol 8.0%

Package Labeling:

Questions Or Comments?

1-800-201-7246

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.


Structured Label Content

Warnings

For external use only.Avoid contact with eyes.

Flammable: Keep away from fire or flame.

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Purpose

Topical Analgesic

Directions

Adults and children 2 years of age and older: • apply directly onto affected area, not more than 3 to 4 times daily • wash hands after use

Children under 2 years of age:do not use, consult a doctor

Other Information

Store at room temperatur

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) 

Active Ingredient

Menthol 8.0%

Package Labeling:

Questions Or Comments? (Questions or comments?)

1-800-201-7246

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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