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| Product NDC Code | 0363-9905 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra large cool and heat 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 | Walgreen Company | ||||
| 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 INGREDIENT Active Ingredient ...............................................................................................Purpose 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 & ADMINISTRATION Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Reseal pouch after opening. Children 12 years or younger: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT CMC, Dihydroxy aluminum Aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
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.INDICATIONS & USAGE For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.
Purpose
Information about the drug product’s indications for use.PURPOSE Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Extra Large Cool and Heat Patch MENTHOL PETROLATUM MINERAL OIL DIHYDROXYALUMINUM AMINOACETATE GLYCERIN KAOLIN METHYLPARABEN SODIUM POLYACRYLATE (2500000 MW) POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN POVIDONE, UNSPECIFIED CARBOXYMETHYLCELLULOSE TARTARIC ACID TITANIUM DIOXIDE WATER MENTHOL MENTHOL
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
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 Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) 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 ■ 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 When using this product ■ Use only as directed ■ Rare cases of serious burns have been reported with products of this type ■ Don’t bandage tightly or use with heating pad ■ Avoid contact with 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