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Drug Facts
First Aid Only First Aid/burn Cream
FDA Label NDC 0924-5011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product First Aid Only First Aid/burn (NDC 0924-5011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzalkonium Chloride 0.13%
Lidocaine HCl 0.5%
Purpose
First Aid Antiseptic
External analgesic
Uses
First aid to help prevent infection and for the temporary relief of pain and itching associated with minor: •cuts •scrapes •burns.
Warnings
For external use only.
Otc - Do Not Use
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
Otc - Stop Use
- 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 ▪a rash or allergic reaction occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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
Other Information
Store in a cool dry area 150 – 250C (590 – 770F)
Inactive Ingredients
butylated hydroxytoluene, ceteth-20, cetostearyl alcohol, dimethicone, glycerin, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, methyl paraben sodium, propylparaben sodium
Otc - Questions
Questions 1.800.835.2263
Package Label.Principal Display Panel
carton label
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