Stopain Extra Strength Gel

Stopain Extra Strength Gel
SPL v7
SPL
SPL Set ID 86fe4e8c-5279-445a-a19a-e694eac785fd
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (80 mg)
Inactive Ingredients
Eucalyptus Oil Glucosamine Sulfate Hydroxypropyl Cellulose, Unspecified Peg-8 Dimethicone Pentylene Glycol Peppermint Oil Trolamine Water Dimethyl Sulfone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-10

Description

Menthol 8.0%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 8.0%

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.

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

Drug Facts

Active Ingredient

Menthol 8.0%

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).

Questions Or Comments?

1-800-201-7246

Package Labeling:473 Ml

Package Labeling:946 Ml

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 

Package Labeling:63936 8800 1

Package Labeling:63936 8800 4

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

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

Warnings

For external use only.Avoid contact with eyes

Flammable: Keep away from fire or flame.

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

Drug Facts

Active Ingredient

Menthol 8.0%

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).

Questions Or Comments? (Questions or comments?)

1-800-201-7246

Package Labeling:473 Ml (Package Labeling:473 mL)

Package Labeling:946 Ml (Package Labeling:946 mL)

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 wihin a few days • redness is present • excessive irritation of the skin develops 

Package Labeling:63936 8800 1 (Package Labeling:63936-8800-1)

Package Labeling:63936 8800 4 (Package Labeling:63936-8800-4)

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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