First Aid Only First Aid/burn Cream
FDA Label NDC 0924-5730

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 0924-5730). 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 active ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, 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.

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.

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 at room temperature

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

* Please review the disclaimer below.