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Profoot pain relief patches - Medication Information

Product NDC Code 29784-601
Drug Name

Profoot pain relief patches

Type Brand
Dosage Form KIT
RxCUI drug identifier 853260
Application Number M017
Labeler Name Profoot, Inc.
Packages
Package NDC Code Description
29784-601-01 1 kit in 1 kit (29784-601-01) * 1 patch in 1 kit / .36 g in 1 patch (29784-121-36) * 2 patch in 1 kit / 1.3 g in 1 patch (29784-122-36)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Camphor 1.2% Menthol 5.7% Methyl salicylate 6.3%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients hydrogenated poly, pentaerythrityl tetra-di-t-butyl Hydroxyhydrocinnamate, white mineral oil, styrene/Isoprene copolymer

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses For temporary relief of minor aches & pains of muscles & joints associated with: •arthritis •strains •bruises •sprains

Purpose

Information about the drug product’s indications for use.
Purpose Topical Analgesic Topical Analgesic Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Profoot Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE PROFOOT CAMPHOR, MENTHOL, METHYL SALICYLATE STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER METHYL SALICYLATE SALICYLIC ACID PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) MINERAL OIL CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL HYDROGENATED C6-20 POLYOLEFIN (100 CST) PROFOOT CAMPHOR, MENTHOL, METHYL SALICYLATE MINERAL OIL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID HYDROGENATED C6-20 POLYOLEFIN (100 CST) STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Label Inner Label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Email [email protected]

Storage and handling

Information about safe storage and handling of the drug product.
Other information • avoid storing in direct sunlight • protect product from excessive moisture

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API

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