Stopain Extra Strength Gel

Stopain Extra Strength Gel
SPL v4
SPL
SPL Set ID fa1a98bc-c233-410d-a20e-71111c897372
Route
TOPICAL
Published
Effective Date 2022-01-19
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 Pentylene Glycol Peppermint Oil Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-24

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

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 Adults and children over 12 years: • 

• repeat if necessary, but do not apply more than 4 times daily.

ask a doctor. Children 12 years or younger:

Active Ingredient

Menthol 8.0%

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 • strains • 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 Adults and children over 12 years: • 

• repeat if necessary, but do not apply more than 4 times daily.

ask a doctor. Children 12 years or younger:

Active Ingredient

Menthol 8.0%

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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