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| Product NDC Code | 41167-0566 | ||||
|---|---|---|---|---|---|
| Drug Name | Aspercreme lidocaine with eucalyptus essential oil |
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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 | CREAM | ||||
| RxCUI drug identifier | 1010895 | ||||
| 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 Lidocaine HCl 4%
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: ■ apply a thin layer to affected area every 6 to 8 hours, 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 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.In active ingredients alcohol denat. (15%), aloe barbadensis leaf juice, C15-19 alkane, caprylic/capric triglyceride, carbomer, cetearyl alcohol, citric acid, ethylhexylglycerin, eucalyptus globulus leaf oil, glycerin, glyceryl stearate, hydroxyacetophenone, potassium hydroxide, polysorbate 60, propanediol, steareth-2, steareth-21, water 373-005 Child-resistant packaging. 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.Use for the temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Aspercreme Lidocaine with Eucalyptus Essential Oil Lidocaine HCl LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS ALOE VERA LEAF C15-19 ALKANE MEDIUM-CHAIN TRIGLYCERIDES CARBOXYPOLYMETHYLENE CETOSTEARYL ALCOHOL CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN EUCALYPTUS OIL GLYCERIN GLYCERYL MONOSTEARATE HYDROXYACETOPHENONE POTASSIUM HYDROXIDE POLYSORBATE 60 PROPANEDIOL STEARETH-2 STEARETH-21 WATER ALCOHOL
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 Aspercreme Lidocaine with Eucalyptus Essential Oil Numbs away pain NET WT 3 oz (85 g) PRINCIPAL DISPLAY PANEL Aspercreme Lidocaine with Eucalyptus Essential Oil Numbs away pain NET WT 3 oz (85 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.Aspercreme Lidocaine with Eucalyptus Essential Oil 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 ■ in large quantities ■ 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
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 Flammable : keep away from fire or flame. Do not use ■ in large quantities ■ 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 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