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| Product NDC Code | 11523-0404 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Solarcaine |
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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 | SPRAY | ||||||
| RxCUI drug identifier | 1010931, 1011767 |
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| Application Number | M016 | ||||||
| Labeler Name | Bayer HealthCare LLC. | ||||||
| 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 ingredient Lidocaine 0.5%
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 shake well adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor to apply to face, spray in palm of hand and gently apply
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aloe barbadensis leaf juice, isobutane, propane, propylene glycol, glycerin, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, carbomer, diazolidinyl urea, methylparaben, propylparaben, disodium cocoamphodipropionate, disodium EDTA
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 pain and itching due to: sunburn minor burns minor cuts scrapes insect bites minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Solarcaine Lidocaine PROPYLPARABEN ALOE VERA LEAF ISOBUTANE PROPANE PROPYLENE GLYCOL GLYCERIN .ALPHA.-TOCOPHEROL ACETATE TROLAMINE DIAZOLIDINYL UREA METHYLPARABEN EDETATE DISODIUM LIDOCAINE LIDOCAINE DISODIUM COCOAMPHODIPROPIONATE Viscous hazy colorless to off-white liquid
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 - 170 g Can Label # 1 Sunburn Relief BRAND PAIN RELIEVING SPRAY WITH Lidocaine Solarcaine ® Cools Instantly Restores Moisture to Sunburned Skin Doctor Tested • Alcohol Free cool aloe burn relief formula NET WT 6 OZ (170g) Can label
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if condition gets worse symptoms last more than 7 days symptoms clear up and occur again in a few days
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.Flammable: Do not use while smoking or near heat or flame
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 gets worse symptoms last more than 7 days symptoms clear up and occur again in 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 Do not use in large quantities, particularly over raw surfaces or blistered areas When using this product keep out of eyes use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
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: Do not use while smoking or near heat or flame When using this product Do not use in large quantities, particularly over raw surfaces or blistered areas When using this product keep out of eyes use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Stop use and ask a doctor if condition gets worse symptoms last more than 7 days symptoms clear up and occur again in a few days 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