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

Purpose

Topical Analgesic

Description

Menthol 8.0%


Medication Information

Warnings

Avoid contact with eyes. For external use only.

Flammable: Keep away from fire or flame.

Purpose

Topical Analgesic

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:

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.

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

Drug Facts

Active Ingredient

Menthol 8.0%

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

Warnings

Avoid contact with eyes. For external use only.

Flammable: Keep away from fire or flame.

Purpose

Topical Analgesic

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:

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.

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains  • bruises  • sprains

Drug Facts

Active Ingredient

Menthol 8.0%

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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