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| Product NDC Code | 52000-033 | ||||
|---|---|---|---|---|---|
| Drug Name | Cold and hot medicated large |
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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 | Universal Distribution Center LLC | ||||
| 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 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 of age and older: Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch Should be used up to 8 hours Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerin, sodium polyacrylate, aluminum glycinate, kaolin, methylparaben, propylparaben, alcohol, titanium dioxide, tartaric acid, sorbitan monooleate, polysorbate 80, purified 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.Uses Temporarily relieve minor aches and pains of muscles and joints due to • simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • 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.Cold and Hot Medicated Large menthol GLYCERIN SODIUM POLYACRYLATE (2500000 MW) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS KAOLIN METHYLPARABEN PROPYLPARABEN ALCOHOL TITANIUM DIOXIDE TARTARIC ACID SORBITAN MONOOLEATE POLYSORBATE 80 WATER MENTHOL, UNSPECIFIED FORM 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.Packaging Largpth-1
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
FAST RELIEF OF MINOR ACHES AND PAINS * Compare to the active ingredient in Icy Hot ® Patch Contains Menthol 5% Pain relieving ointment on a breathable adhesive pad EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours . The thin, flexible patch is comfortable to wear and is easy to remove. *This product is NOT manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot ® Patch. Distributed by: Universal Distribution Center 96 Distribution Boulevard • Edison, NJ 08817
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 (1-800-222-1222) immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 68° to 77°F (20 to 25°C)
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: EXTERNAL USE ONLY When using this product USE ONLY AS DIRECTED . • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin. STOP USE and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops If pregnant or breast-feeding, 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