Active Ingredients Purpose
LIDOCAINE HYDROCHLORIDE Pain Reliever
Burn Relief Aloe Gel
FDA Label NDC 80551-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acutens for the product Burn Relief Aloe (NDC 80551-001). 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 for external use only, direction, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
For temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation
Warnings For External Use Only
When using this product • Avoid contact with eyes. Rinse with water if contact occurs.
Stop use and ask doctor if • symptoms persist for more than 7 days or clear up and occur again within a few days.
Do not use in large quantities, particularly over raw surfaces or blistered area
Direction
adults and children over 2 years and older: • Apply to affected area not more than 3-4 times a day
• Children under 2 years old: consult a doctor
Inactive Ingredients
Aloe Barbadensis Leaf Extract
Avena Sativa (Oat) Kernel Extract
Blue 1
Caprylyl Glycol
Chlorphenesin
Dimethyl Isosorbide
Glycerin
Hydroxyethylcellulose
Isopropyl Alcohol
Phenoxyethanol
Polysorbate 20
Propanediol
Tocopheryl Acetate
Water
* Please review the disclaimer below.
