Profoot Pain Relief Patches

Profoot Pain Relief Patches
SPL v3
SPL
SPL Set ID 06f82bde-41a1-35f6-e063-6394a90a6437
Route
TOPICAL
Published
Effective Date 2019-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (63 mg) Camphor (natural) (12 mg) Menthol (57 mg)
Inactive Ingredients
Styrene/isoprene/styrene Block Copolymer Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Mineral Oil Hydrogenated C6-20 Polyolefin (100 Cst)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-10-12 Until 2027-05-31

Description

Active ingredients Camphor 1.2% Menthol 5.7% Methyl salicylate 6.3%


Medication Information

Warnings and Precautions

Warnings

For external use only

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

Do not use

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

this product

When using this product

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

bandage tightly

Stop use and ask a doctor if

• rash, itching or excessive skin irritation develops • condition worsens •symptoms persist

for more than 7 days • symptoms clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Indications and Usage

Uses For temporary relief of minor aches & pains of muscles & joints associated with:

•arthritis •strains •bruises •sprains

Dosage and Administration

Directions

Adults and children 12 years of age and over:

• clean and dry affected area • remove patch from film • 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

Description

Active ingredients Camphor 1.2% Menthol 5.7% Methyl salicylate 6.3%

Section 44425-7

Other information

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control

Center right away

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions or comments? Email [email protected]

Section 55105-1

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Section 55106-9

Active ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%


Structured Label Content

Indications and Usage (34067-9)

Uses For temporary relief of minor aches & pains of muscles & joints associated with:

•arthritis •strains •bruises •sprains

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and over:

• clean and dry affected area • remove patch from film • 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

Warnings and Precautions (34071-1)

Warnings

For external use only

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

Do not use

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

this product

When using this product

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

bandage tightly

Stop use and ask a doctor if

• rash, itching or excessive skin irritation develops • condition worsens •symptoms persist

for more than 7 days • symptoms clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control

Center right away

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Email [email protected]

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%


Advanced Ingredient Data


Raw Label Data

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