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| Product NDC Code | 29784-600 | ||||
|---|---|---|---|---|---|
| Drug Name | Profoot pain relief patches |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 853260 | ||||
| Application Number | M017 | ||||
| Labeler Name | Rooftop Consumer Health, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 : consult a doctor Children under 12 years of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.hydrogenated poly, pentaerythrityl tetra-di-t-butyl Hydroxyhydrocinnamate, white mineral oil, styrene/Isoprene copolymer Inactive ingredients
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.For temporary relief of minor aches & pains of muscles & joints associated with: Uses •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 HYDROGENATED C6-20 POLYOLEFIN (100 CST) STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) MINERAL OIL METHYL SALICYLATE SALICYLIC ACID CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL PROFOOT CAMPHOR, MENTHOL, METHYL SALICYLATE HYDROGENATED C6-20 POLYOLEFIN (100 CST) STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER MINERAL OIL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID
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.image description image description Carton
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.. If swallowed, get medical help or contact a Poison Control Keep out of reach of children 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.Call 1.800.526.3668 or email [email protected] Questions or comments?
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 If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Allergy alert: 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 ask a health professional before use. If pregnant or breastfeeding,
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