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| Product NDC Code | 41167-0801 | ||||
|---|---|---|---|---|---|
| Drug Name | Icy hot advanced relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1373219 | ||||
| Application Number | M017 | ||||
| Labeler Name | Chattem, Inc. | ||||
| 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 i ngredient s Menthol 16% Camphor 11%
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 a dults and children over 12 years: apply a thin layer to affected area message into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications AFTER APPLYING, WASH HANDS WITH SOAP AND WATER Children 12 years and younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice, cetyl alcohol, diisopropyl adipate, disodium EDTA, ethoxydiglycol, fragrance, glycerin, glyceryl stearate, menthyl lactate, methylparaben, PEG-150 sterate, pentylene glycol, 4-t-butylcyclohexanol, phenoxyethanol, polysorbate 80, propanediol, SD alcohol (5% w/w), glycine soja (soybean) sterols, steareth-21, stearic acid, triethanolamine, water, xanthan gum (309-018)
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 relieves minor pain associated with: arthritis simple backache muscle strains 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.Icy Hot Advanced Relief Camphor and Menthol CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL ALLANTOIN ALOE VERA LEAF CETYL ALCOHOL DIISOPROPYL ADIPATE EDETATE DISODIUM DIETHYLENE GLYCOL MONOETHYL ETHER GLYCERIN GLYCERYL MONOSTEARATE MENTHYL LACTATE, (-)- METHYLPARABEN PEG-150 STEARATE PENTYLENE GLYCOL 4-TERT-BUTYLCYCLOHEXANOL PHENOXYETHANOL POLYSORBATE 80 PROPANEDIOL SOY STEROL STEARETH-21 STEARIC ACID TROLAMINE WATER XANTHAN GUM CARBOMER INTERPOLYMER TYPE A (55000 CPS)
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 PAIN RELIEF CREAM Net WT 2 OZ (56 g) Principal Display Panel ICY HOT® ADVANCED PAIN RELIEF CREAM Net WT 2 OZ (56 g)
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
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 redness is present irritation 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 bandage tightly or use with a heating pad, or medicated patch avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears within a few days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant of 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 When using this product use only as directed do not bandage tightly or use with a heating pad, or medicated patch avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears within a few days 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 If pregnant of 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