Stopain Clinical Gel

Stopain Clinical Gel
SPL v11
SPL
SPL Set ID 4503208f-2808-4727-8066-c431230bd70b
Route
TOPICAL
Published
Effective Date 2021-09-21
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 2017-01-18

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
  • strains
  • bruises
  • sprains
Warnings

​Avoid contact with eyes. ​For external use only.

Flammable: Keep away from fire or flame.

Directions

​Adults and children over 12 years:

ask a doctor.​​ ​Children 12 years or younger:

  • apply directly onto affected area without the need to bandage
  • repeat if necessary, but do not apply more than 4 times daily.
Active Ingredient

Menthol 10.0%

Other Information 
  • Store at room temperature
Inactive Ingredients

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, triethanolamine, water (USP).

Package Labeling:118ml

Package Labeling:473ml

Package Labeling:946ml

Package Labeling:3785ml

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

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

​Adults and children over 12 years:

ask a doctor.​​ ​Children 12 years or younger:

  • apply directly onto affected area without the need to bandage
  • repeat if necessary, but do not apply more than 4 times daily.
Active Ingredient

Menthol 10.0%

Other Information 
  • Store at room temperature
Inactive Ingredients

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, triethanolamine, water (USP).

Package Labeling:118ml

Package Labeling:473ml

Package Labeling:946ml

Package Labeling:3785ml

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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