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| Product NDC Code | 62168-0086 | ||||
|---|---|---|---|---|---|
| Drug Name | Dorflex icy hot flexible, large |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222, 1432289 |
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| Application Number | 505G(a)(3) | ||||
| Labeler Name | Lead Chemical Co., Ltd. | ||||
| 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 • Remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle • Carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area • Once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area Children 12 years or younger, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, 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.Uses Dorflex Icy Hot is indicated for bruises, traumas, muscle pains, cramps, torticollis and painful and inflammatory processes at large.
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.Dorflex Icy Hot Flexible, Small Menthol MENTHOL MENTHOL ACRYLIC ACID ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 2-ETHYLHEXYL ACRYLATE GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 SODIUM POLYACRYLATE (2500000 MW) POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SORBITAN SESQUIOLEATE STARCH, CORN TALC TARTARIC ACID TITANIUM DIOXIDE WATER Dorflex Icy Hot Flexible, Large Menthol MENTHOL MENTHOL ACRYLIC ACID ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 2-ETHYLHEXYL ACRYLATE GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN TALC TARTARIC ACID TITANIUM DIOXIDE WATER
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.Principal Display Panel - Small Dorflex ICY HOT ® Flexible Patch • Muscle pain • Bruises • Cramps • Torticollis Lasts up to 8 hours Contains 5 Patches in 1 Resealable Pouch Cut open pouch and remove pad Reseal pouch after opening Pouch Label - Small image-01
Principal Display Panel - Large Dorflex ICY HOT ® Flexible Patch • Muscle pain • Bruises • Cramps • Torticollis Lasts up to 8 hours Contains 5 Patches in 1 Resealable Pouch Cut open pouch and remove pad Reseal pouch after opening Pouch Label - Large image-03
Instructions for use
Information about safe handling and use of the drug product.Precautions • Do not wear the same patch for more than 8 hours. • Do not wear more than 3 patches daily. • Store in ambient temperature. • Use each patch only once.
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 by accident, get medical help.
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. • Irritation or redness develops. • Symptoms persist for more than 7 days or 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. • Do not use with a heating pad. • Avoid contact with eyes and mucous membranes. • Do not apply to wounds or damaged, broken or irritated skin.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor 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 For use in adults and children over 12 years. When using this product • Use only as directed. • Do not use with a heating pad. • Avoid contact with eyes and mucous membranes. • Do not apply to wounds or damaged, broken or irritated skin. Stop use and ask a doctor if • Condition worsens. • Irritation or redness develops. • Symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. If swallowed by accident, get medical help.
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