Stopain Clinical

Stopain Clinical
SPL v3
SPL
SPL Set ID 3336cc35-e773-4705-84b5-61040604beef
Route
TOPICAL
Published
Effective Date 2023-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg)
Inactive Ingredients
Dimethyl Sulfone Eucalyptus Oil Glucosamine Sulfate Hydroxypropyl Cellulose, Unspecified Peg-8 Dimethicone Pentylene Glycol Peppermint Oil Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-31

Description

Menthol 10.0%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 10.0%

Uses

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

Warnings

Avoid contact with eyes. For external use only.

Flammable: Keep away from fire or flame.

Directions

• apply directly onto affected area without the need to bandage • repeat if necessary, but do not apply more than 4 times daily. Adults and children over 12 years: 

ask a doctor. Children 12 years of younger:

Drug Facts

Active Ingredient

Menthol 10.0%

Other Information

• Store at room temperature

Package Labeling:

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).

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

Uses

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

Purpose

Topical Analgesic

Warnings

Avoid contact with eyes. For external use only.

Flammable: Keep away from fire or flame.

Directions

• apply directly onto affected area without the need to bandage • repeat if necessary, but do not apply more than 4 times daily. Adults and children over 12 years: 

ask a doctor. Children 12 years of younger:

Drug Facts

Active Ingredient

Menthol 10.0%

Other Information

• Store at room temperature

Package Labeling:

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).

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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