Active Ingredients
Benzalkonium chloride 0.13%
Lidocaine HCl 0.5%
First Aid Burn Cream
FDA Label NDC 59898-902
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Water-jel Technologies for the product First Aid Burn (NDC 59898-902). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 or apply over large areas of the body
- longer than 1 week unless directed by a doctor
- in large quantities, particularly over raw surfaces or blistered areas
Ask A Doctor Before Use If You Have
deep or puncture wounds, animal bites, or serious burns
When Using This Product
avoid contact with eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days
- condition clears up and occurs again within a few days
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older:
- clean the affected area
- apply a small amount of this product on the area 1 to 3 times daily
- may be covered with a sterile bandage
- children under 2 years of age: consult a doctor
Other Information
- store at room temperature (do not freeze)
- tamper evident sealed packets
- do not use if packet is opened or torn
- you may report a serious reaction to this product to 800-275-3433
Inactive Ingredients
water, mineral oil, stearic acid, glyceryl stearate se, glycerin, Peg-100, cetyl alcohol, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, aloe barbadensis leaf juice, triethanolamine, disodium EDTA
Questions?
800-275-3433 [email protected] www.waterjel.com
* Please review the disclaimer below.
