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| Product NDC Code | 62168-1720 | ||||
|---|---|---|---|---|---|
| Drug Name | Icy hot |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Lead Chemical Co. Ltd. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Lidocaine 4% Menthol 1%
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: • clean and dry affected area • 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 • use 1 patch at a time and not 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 aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, 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 for the temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purposes Topical anesthetic Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Icy Hot Lidocaine, Menthol LIDOCAINE LIDOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM GLYCERIN METHYLPARABEN NONOXYNOL-30 POLYSORBATE 80 PROPYLENE GLYCOL SILICON DIOXIDE TARTARIC ACID TITANIUM DIOXIDE UREA 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.Package/Label Principal Display Panel LIDOCAINE 4% + MENTHOL 1% ICY HOT® MAX Pain Relief Patch LIDOCAINE PATCH • Maximum Strength Lidocaine Without a Prescription* • Penetrates for Fast, Targeted Relief • Comfortable Fabric • Stays in Place *Among OTC Topical Analgesics Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm) CHATTEM® A SANOFI COMPANY Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Label image-01
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 puncture wounds, cuts, irritated, damaged or swollen skin • more than 1 patch on your body at a time or with other topical analgesics at the same time • with a heating pad or apply local heat to the area of use
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 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 or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • severe burning sensation, redness, or irritation develops • 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 • do not bandage tightly • avoid contact with the eyes and mucous membranes • rare cases of serious burns have been reported with products of this type • a transient burning sensation may occur upon application but generally disappears in several days • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, 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