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| Product NDC Code | 11822-6513 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength cold and hot menthol patch |
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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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| 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 Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic
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.Dosage and Administration Directions Adults and children 12 years of age and over : ■ Carefully remove backing from patch ■ Apply sticky side of patch to affected area. ■ Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily.. ■ Discard patch after single use. ■Reseal pouch after opening. ■Children under 12 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerin, iodopropynyl butylcarbamate, Kaolin, mineral oil, petrolatum, Phenoxyethanol, polyacrylic acid, Polysorbate 80, Povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol
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 pain.
Purpose
Information about the drug product’s indications for use.Uses Temporarily relieves minor pain.
Spl product data elements
Usually a list of ingredients in a drug product.Extra Strength Cold and Hot Menthol Patch MENTHOL CARBOXYMETHYLCELLULOSE SODIUM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM PETROLATUM DIHYDROXYALUMINUM AMINOACETATE GLYCERIN KAOLIN POLYACRYLIC ACID (8000 MW) PHENOXYETHANOL POLYSORBATE 80 POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (8000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER IODOPROPYNYL BUTYLCARBAMATE ETHYLHEXYLGLYCERIN MINERAL OIL
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.Extra Strength Cold & Hot Menthol Patch 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 and pets. If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Safety Information Store at room temperature, not to exceed 86F (30C)
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 consult a doctor ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.
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 ■ rear cases of serious burns have been reported with products of this type ■ Don't bandage tightly or use with a heating pad ■ Avoid contact with the eyes and mucous membranes ■Don't apply to wounds or damaged skin ■ Do not use at the same time as other topical analgesics
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, 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.
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