Profoot
FDA Label NDC 29784-122

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Profoot, Inc. for the product Profoot (NDC 29784-122). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

Otc - Purpose

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Indications & Usage

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

•arthritis •strains •bruises •sprains

Warnings

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.

Otc - 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

Dosage & 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

Storage And Handling

Other information

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

Inactive Ingredient

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

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