Drugplain

First Aid Burn Cream 13 mg/10000mg

First Aid Burn Cream · CREAM · Front Line Safety

1 Recall on Record
Plain English

First Aid Burn Cream is a topical cream applied directly to the skin to help treat minor burns and wounds. It is available over-the-counter without a prescription.

Key Facts

Brand Name
First Aid Burn Cream
Generic Name
First Aid Burn Cream
NDC Code (Product)
58228-6244
Manufacturer
Front Line Safety
Strength
13 mg/10000mg
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
01/26/2024

Recall History

1 Recall on Record
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use(s) For the temporary relief of pain and itching associated with: • Sunburn • Minor burns • Insect bites • Cuts • Scrapes

Dosage & Administration

Directions Adults and children 2 years and over: • Clean the affected area • Apply a small amount of this product on the area 3 to 4 times daily • May be covered with a sterile bandage Children under 2 years: • Consult a doctor

Warnings

Warnings For External Use Only. Do not use • In the eyes • Over large areas of the body or on deep puncture wounds, animal bites, or serious burns • In large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if • The condition gets worse • Condition clears up and recurs within a few days • Condition persists for more than 7 days If pregnant or breast feeding Ask a health care professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is First Aid Burn Cream used for?

First Aid Burn Cream is a topical cream applied directly to the skin to help treat minor burns and wounds. It is available over-the-counter without a prescription.

Is First Aid Burn Cream a controlled substance?

First Aid Burn Cream is not classified as a controlled substance by the DEA.

What is the generic name for First Aid Burn Cream?

The generic name for First Aid Burn Cream is First Aid Burn Cream. There are no other listed brand versions of First Aid Burn Cream.

What is the NDC code for First Aid Burn Cream 13 mg/10000mg?

The NDC (National Drug Code) for First Aid Burn Cream 13 mg/10000mg is 58228-6244, listed by Front Line Safety.

Product NDC

58228-6244

Package NDC

58228-6244-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)