Stopain Clinical Roll-on

Stopain Clinical Roll-on
SPL v7
SPL
SPL Set ID 27703209-fdac-4620-a445-d89a84bc853d
Route
TOPICAL
Published
Effective Date 2021-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg)
Inactive Ingredients
Indian Frankincense Carbomer Homopolymer, Unspecified Type Dimethyl Sulfone Eucalyptus Oil Glucosamine Sulfate Glycerin 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:

  • roll directly onto affected area without the need to rub, massage or bandage
  • repeat if necessary, but do not apply more than 4 times daily.
Drug Facts

Active Ingredient

Menthol 10.0%

Other Information
  • Store at room temperature
Package Labeling:

Inactive Ingredients

boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerine, 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 if present 
  • excessive irritation of the skin develops
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding, 

ask a health professional before use.


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:

  • roll directly onto affected area without the need to rub, massage or bandage
  • repeat if necessary, but do not apply more than 4 times daily.
Drug Facts

Active Ingredient

Menthol 10.0%

Other Information
  • Store at room temperature
Package Labeling:

Inactive Ingredients

boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerine, 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 if present 
  • excessive irritation of the skin develops
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.

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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