Extra Strength Stopain Cold Pain Relieving Liquid Roll On

Extra Strength Stopain Cold Pain Relieving Liquid Roll On
SPL v11
SPL
SPL Set ID 895896dc-0762-40a7-8313-cca10ce68984
Route
TOPICAL
Published
Effective Date 2023-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (80 mg)
Inactive Ingredients
Indian Frankincense Carbomer Homopolymer, Unspecified Type Dimethyl Sulfone Eucalyptus Oil Glucosamine Sulfate Glycerin Peppermint Oil Alcohol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-10-13

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

roll directly onto affected area without the need to rub, massage or 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:

Drug Facts

Active Ingredient

Menthol 8.0%

Other Information

• Store at room temperature.

Inactive Ingredients

boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, 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

Keep Out of Reach of Children.

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

Package Labeling: 63936 8523 1

Package Labeling: 63936 8523 2

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

roll directly onto affected area without the need to rub, massage or 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:

Drug Facts

Active Ingredient

Menthol 8.0%

Other Information (Other information)

• Store at room temperature.

Inactive Ingredients

boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, 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

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.

Package Labeling: 63936 8523 1 (Package Labeling: 63936-8523-1)

Package Labeling: 63936 8523 2 (Package Labeling: 63936-8523-2)

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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