Profoot Plantar Relief Strips

Profoot Plantar Relief Strips
SPL v2
SPL
SPL Set ID 65e142d8-da21-4c55-9faf-b387cb6c2c0e
Route
TOPICAL
Published
Effective Date 2023-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (12 mg) Menthol (57 mg) Salicylic Acid (63 mg)
Inactive Ingredients
Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-10-18 Until 2027-05-31

Description

Camphor 1.2% Menthol 5.7% Methyl salicylate 6.3%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 1.2% Menthol 5.7% Methyl salicylate 6.3%

Uses

For temporary relief of minor aches & pains of muscles & joints associated with: • arthritis • strains • bruises • sprains

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Directions

Adults and children 12 years of age and over:

• clean and dry affected area • hold patch wide end up to make a "I" shape • only peel off film on wide end first, stopping halfway • apply patch so that wings wrap around arch •remove remaing film & pull back to wrap around heel • apply to affected area not more than 3-4 times daily • remove patch from skin after at most 8 hours

Children under 12 years of age:consult a doctor 

Do Not Use

• on wounds or damaged skin • with a heating pad • if you are allergic to any ingredients of this product

Other Information

• avoid storing in direct sunlight • protect product from excessive moisture

Package Labeling:

Active Ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

Inactive Ingredients

hydrogenated poly, pentaerythrityl tetra-di-t-butyl Hydroxyhydrocinnamate, white mineral oil, styrene/Isoprene copolymer

Questions Or Comments?
When Using This Product

• use only as directed • avoid contact with the eyes, mucocus membranes or rashes • do not bandage tightly

Stop Use and Ask A Doctor If

• rash, itching or excessive skin irritation develops • condtions worsen • symtomps persist for more than 7 days • symptoms clean up and occur again within a few days

Keep Out of Reach of Children.

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

If Pregnant Or Reach of Children.

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


Structured Label Content

Uses

For temporary relief of minor aches & pains of muscles & joints associated with: • arthritis • strains • bruises • sprains

Purpose

Topical Analgesic

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Directions

Adults and children 12 years of age and over:

• clean and dry affected area • hold patch wide end up to make a "I" shape • only peel off film on wide end first, stopping halfway • apply patch so that wings wrap around arch •remove remaing film & pull back to wrap around heel • apply to affected area not more than 3-4 times daily • remove patch from skin after at most 8 hours

Children under 12 years of age:consult a doctor 

Do Not Use (Do not use)

• on wounds or damaged skin • with a heating pad • if you are allergic to any ingredients of this product

Other Information (Other information)

• avoid storing in direct sunlight • protect product from excessive moisture

Package Labeling:

Active Ingredients (Active ingredients)

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

Inactive Ingredients (Inactive ingredients)

hydrogenated poly, pentaerythrityl tetra-di-t-butyl Hydroxyhydrocinnamate, white mineral oil, styrene/Isoprene copolymer

Questions Or Comments? (Questions or comments?)
When Using This Product (When using this product)

• use only as directed • avoid contact with the eyes, mucocus membranes or rashes • do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash, itching or excessive skin irritation develops • condtions worsen • symtomps persist for more than 7 days • symptoms clean up and occur again within a few days

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 Reach of Children. (If pregnant or reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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