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| Product NDC Code | 68229-201 | ||||||||||||||||||||||
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| Drug Name | Alocane emergency burn |
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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 | GEL | ||||||||||||||||||||||
| RxCUI drug identifier | 1010077, 1875237 |
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| Application Number | M017 | ||||||||||||||||||||||
| Labeler Name | Quest Products, 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 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.Do not use in large quantities, particularly over raw surfaces or blistered areas. Directions: Adults and Children 2 years of age or older: Clean the burn area with mild soap and water Gently apply over bthe burn or wound Use on affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
Directions: Adults and Children 2 years of age or older: Clean the burn area with mild soap and water Gently apply over bthe burn or wound Use on affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients 1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.
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 pain and itching associated with: Sunburn Minor Skin Irritation Minor Burns Cuts & Scrapes Insect Bites
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.Alocane Emergency Burn Lidocaine Hydrochloride PROPANEDIOL ALOE VERA LEAF DIMETHYL ISOSORBIDE HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) PHENOXYETHANOL CAPRYLYL GLYCOL CHLORPHENESIN .ALPHA.-TOCOPHEROL ACETATE WATER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 - ALOCANE Burn Gel 2.5 fl oz tube 201-02
PRINCIPAL DISPLAY PANEL -- ALOCANE Burn Gel Pump 201-14
PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel Single Use 45 Count 45SingleUse
PRINCIPAL DISPLAY PANEL - ALOCANE Burn Spray 3.5 fl oz 201.08
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
Distributed by: Quest Products, LLC. Pleasant Prairie, WI 53158
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. In case of accidental ingestion, 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 doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health care professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature 15-30°C (59-86°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. Avoid contact with eyes. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away. Stop use and ask doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding , ask a health care professional before use. Do not use in large quantities, particularly over raw surfaces or blistered areas. Directions: Adults and Children 2 years of age or older: Clean the burn area with mild soap and water Gently apply over bthe burn or wound Use on affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
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