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| Product NDC Code | 41167-0805 | ||||
|---|---|---|---|---|---|
| Drug Name | Icy hot advanced relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1010823 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Chattem, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 7.5%
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: ■ gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain. ■ remove remaining film backing from both sides and finish applying to skin ■ apply to affected area 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 glyceryl hydrogenated rosinate, hydrated silica, mineral oil, PEG-400, polyisobutene, styrene/isoprene copolymer
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 for the temporary relief of minor aches and pains of muscles and joints associated with: ■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises
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.Icy Hot Advanced Relief Menthol Topical Analgesic MENTHOL MENTHOL HYDRATED SILICA MINERAL OIL POLYETHYLENE GLYCOL 400 POLYISOBUTYLENE (1000 MW) GLYCEROL ESTER OF HYDROGENATED ROSIN STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER
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 ICY HOT ® ADVANCED RELIEF PAIN RELIEF PATCH ADVANCED RELIEF at the POINT of PAIN 50% MORE MEDICINE LONG LASTING RELIEF FLEXIBLE, NO MESS FABRIC Easy to Apply and Remove Contains 4 Patches in 1 Resalable Pouch 3 15/16” x 5 ½” (10 cm x 14 cm) each Principal Display Panel ICY HOT® ADVANCED RELIEF PAIN RELIEF PATCH ADVANCED RELIEF at the POINT of PAIN 50% MORE MEDICINE LONG LASTING RELIEF FLEXIBLE, NO MESS FABRIC Easy to Apply and Remove Contains 4 Patches in 1 Resalable Pouch 3 15/16” x 5 ½” (10 cm x 14 cm) each
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, damaged, broken or irritated skin ■ 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. 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 develop ■ 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 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
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 Do not use ■ on wounds, damaged, broken or irritated skin ■ with a heating pad or apply local heat to the area of use When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with 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 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 develop ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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