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| Product NDC Code | 41167-0799 | ||||
|---|---|---|---|---|---|
| Drug Name | Icy hot kids pain relief roll-on |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 283438 | ||||
| Application Number | M017 | ||||
| Labeler Name | Chattem, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient
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 ■ children 2 years of age and older: ■ apply a thin layer to affected area not more than 3 to 4 times daily ■ massage until thoroughly absorbed into skin ■ wash hands thoroughly with soap and water after each use ■ children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients allantoin, aloe barbadensis leaf juice, carbomer, citric acid, diisopropyl adipate, ethylhexylglycerin, glycerin, hydroxyacetophenone, potassium hydroxide, steareth-2, steareth-21, water PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION . Close cap tightly after use. Keep carton as it contains important information.
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 aches and pains of muscles and joints associated with: ■ strains ■ sprains ■ bruises ■ simple backache
Purpose
Information about the drug product’s indications for use.Purpose Menthol 4%.........................................................................................................................Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Icy Hot Kids Pain Relief Roll-On Menthol MENTHOL MENTHOL ALLANTOIN ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CITRIC ACID MONOHYDRATE DIISOPROPYL ADIPATE ETHYLHEXYLGLYCERIN GLYCERIN HYDROXYACETOPHENONE POTASSIUM HYDROXIDE STEARETH-2 STEARETH-21 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 Icy Hot Kids Pain Relief Roll-On 1.5 FL OZ (44.3 mL) ROLL-ON PRINCIPAL DISPLAY PANEL Icy Hot Kids Pain Relief Roll-On 1.5 FL OZ (44.3 mL) ROLL-ON
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.Icy Hot Kids Pain Relief Roll - On Drug Facts
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 or on irritated or damaged skin ■ with a heating pad
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 ■ redness is present or excessive skin irritation occurs ■ you experience severe burning 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 ■ do not expose the area to local heat or to direct sunlight ■ 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 ■ avoid applying into skin folds
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 or on irritated or damaged skin ■ with a heating pad When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ 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 ■ avoid applying into skin folds 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 ■ redness is present or excessive skin irritation occurs ■ you experience severe burning 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