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Product NDC Code | 11822-3729 | ||||
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Drug Name | Rite aid cold and hot medicated |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 420222 | ||||
Application Number | part348 | ||||
Labeler Name | Rite Aid Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 5%
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 and over: apply patch to affected area as needed but no more than 4 times daily children under 12 years: ask a doctor for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until backing separates. Remove protective film while applying pad directly to site of pain.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid
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 temporarily relieves minor aches and pains of muscles and joints due to arthritis bursitis simple backache tendonitis strains bruises sprains cramps
Purpose
Information about the drug product’s indications for use.Purpose Menthol - Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Rite Aid Cold and Hot Medicated Menthol CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM CASTOR OIL DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM GLYCERIN HYDROXYPROPYL CELLULOSE, UNSPECIFIED KAOLIN POLYACRYLIC ACID (250000 MW) POLYVINYL ALCOHOL, UNSPECIFIED WATER SORBITOL TARTARIC ACID MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM
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.Package/Label Principal Display Panel Rite Aid Cold & Hot Medicated Patch
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if excessive redness or irritation is present condition worsens pain persists for more than 7 days symptoms clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product use only as directed avoid contact with eyes or on mucous membranes do not apply to wounds or to damaged or very sensitive skin do not bandage tightly or use a heating pad
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 When using this product use only as directed avoid contact with eyes or on mucous membranes do not apply to wounds or to damaged or very sensitive skin do not bandage tightly or use a heating pad Stop use and ask a doctor if excessive redness or irritation is present condition worsens pain persists for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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