Active Ingredient
Benzalkonium Chloride 0.13%
Lidocaine Hydrochloride 0.5%
First Aid Burn Cream
FDA Label NDC 58228-2044
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prostat First Aid Llc for the product First Aid Burn Cream (NDC 58228-2044). 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 ingredient, purpose, use(s), warnings, do not use, stop use and ask a dioctor if, if pregnant or breast feeding, 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
Purpose
Benzalkonium Chloride Topical Antiseptic
Lidocaine Hydrochloride Topical Analgesic
Use(S)
• For the temporary relief of pain and itching associated with:
• Sunburn • Minor burns • Insect bites • Minor skin irritation • Cuts • Scrapes
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 Dioctor 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.
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
Other Information
• Store in a cool, dry area 15°-25°C (59°-77°F)
• Tamper evident sealed packets
• Do not use any opened or torn packets
Inactive Ingredients
Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben
Questions?
1-888-900-2920 Monday - Friday 8AM - 4PM PST.
Label
Ps-2044-bx-master (Ps 2044 Bx Master R230123 11)
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