stopain clinical maximun perfomance pain relief

stopain clinical maximun perfomance pain relief
SPL v4
SPL
SPL Set ID 40df30ba-41ba-42b7-93fe-4183b57bdb00
Route
topical
Published
Effective Date 2025-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (100 mg)
Inactive Ingredients
acrylic acid 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 2022-11-30

Purpose

Topical Analgesic

Description

Menthol 10.0%


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

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 10.0%

Drug Facts

Active Ingredient

Menthol 10.0%

Package Labeling:

Other Information 
  • Store at room temperature
Question 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
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.

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

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

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)

Drug Facts

Active Ingredient

Menthol 10.0%

Package Labeling:

Other Information 
  • Store at room temperature
Question Or Comments? (Question 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
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.

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

Advanced Ingredient Data


Raw Label Data

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