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Product NDC Code | 83569-001 | ||||
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Drug Name | Rapid relief cold relief patch |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 259546 | ||||
Application Number | M017 | ||||
Labeler Name | RAPID AID VIET NAM CO., LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Menthol 4.26% w/w
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 For use by adults and children 12 years of age and older: 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 Glycerin, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Dihydroxyaluminum aminoacetate, DMDM hydantoin, Isopropyl myristate, Edetic acid, 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.Use Temporary relief of minor pain.
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.Rapid Relief Cold Relief Patch Menthol Menthol MENTHOL POLYSORBATE 80 POLYACRYLIC ACID (450000 MW) POLYVINYL ALCOHOL, UNSPECIFIED Propylene glycol Glycerin Water DMDM hydantoin Edetic acid SODIUM POLYACRYLATE (8000 MW) Dihydroxyaluminum aminoacetate Isopropyl myristate Tartaric acid Titanium dioxide
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 image description
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use On wounds, cuts, damaged or infected skin On eyes, mouth, genitals, or any other mucous membranes
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 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 if: 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. If pregnant or breastfeeding, ask a health professional before use.
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 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. Do not use at the same time as other topical analgesics.
Storage and handling
Information about safe storage and handling of the drug product.STORAGE AND HANDLING Store between 15-30℃(59-86℉) keep away from children
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