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| Product NDC Code | 0924-5730 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | First aid only first aid/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 | CREAM | ||||||||
| RxCUI drug identifier | 1012100 | ||||||||
| Application Number | M003 | ||||||||
| 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 Ingredients Benzalkonium chloride 0.13% Lidocaine HCL 0.5% Purpose First Aid Antiseptic External Analgesic
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 - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily. Children under 2- Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients butylated hydroxytoluene, cetostearyl alcohol, dimethicone, edetate sodium, glycerin, glyceryl monostearate, isopropyl myristate, macrogol cetostearyl ether 20, methylcellulose, purified water, sodium methylparaben, sodium propylparaben
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 First aid to help prevent infection and for the temporary relief of pain and itching associated with minor: • cuts, •scrapes, •burns.
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antiseptic External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.First Aid Only First Aid/Burn LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE BUTYLATED HYDROXYTOLUENE CETOSTEARYL ALCOHOL DIMETHICONE GLYCERIN GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE WATER EDETATE SODIUM METHYLPARABEN SODIUM PROPYLPARABEN SODIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM
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 Label Carton 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
Other Information Store at room temperature
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 the eyes ▪over large areas of the body ▪in large quantities, particularly over raw surfaces or blistered areas ▪if you are allergic to any of the ingredients ▪on deep puncture wounds, animal bites, or serious burns
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1.800.835.2263
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 clears up and occurs again within a few days ▪symptoms persist for more than 7 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. Do not use ▪in the eyes ▪over large areas of the body ▪in large quantities, particularly over raw surfaces or blistered areas ▪if you are allergic to any of the ingredients ▪on deep puncture wounds, animal bites, or serious burns Stop use and ask a doctor if ▪condition worsens or clears up and occurs again within a few days ▪symptoms persist for more than 7 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