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| Product NDC Code | 0924-5010 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | First aid only 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 | 1011852 | ||||||||
| Application Number | part348 | ||||||||
| Labeler Name | Acme United Corporation | ||||||||
| 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 Hydrochloride 2%
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 2 years and over: 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: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.
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 associated with minor burns
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.First Aid Only Burn Lidocaine Hydrochloride TEA TREE OIL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) GLYCERIN PROPYLENE GLYCOL IMIDUREA TROLAMINE WATER METHYLPARABEN PROPYLPARABEN 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.Carton Image
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.QUESTIONS 800-835-2263
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, particularly over raw surfaces or blistered areas
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 Poison Control immediately
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 ▪symptoms persist for more than 7 days ▪symptoms clear up and occur again in a few days
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 Do not use ▪ in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if ▪condition worsens ▪symptoms persist for 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 Poison Control immediately
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