Active Ingredient
Lidocaine 0.5%
Burn Relief
FDA Label NDC 70281-640
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Solskyn Personal Care Llc for the product Burn Relief (NDC 70281-640). 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, dosage & administration, warnings, do not use, 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
External analgesic
Use
INDICATIONS & USAGE SECTION
Temporarily relieves pain and itching due to:
• Sunburn • Minor burns
• Minor cuts • Scrapes
• Insect bites • Minor skin irritations
Dosage & Administration
For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.
Warnings
For external use only.
Do Not Use
Do not use in large quantities, particularly over raw surfaces or
blistered areas.
When Using This Product:
When using this product:
• Keep out of eyes.
• Use only as directed.
• Do not puncture or incinerate. Contents under pressure. Do
not store at temperature above 120°F.
Stop Use And Ask A Doctor If:
Stop use and ask a doctor if:
• Condition gets worse
• Symptoms last more than 7 days
• Symptoms clear up and occur again in a few days
Keep Out Of Reach Of Children.
Keep out of reach of children. If swallowed, get medical help or
contact Poison Control Center right away.
Directions
• Shake well
• Adults and children 2 years of age and older: apply to
affected area not more than 3 to 4 times daily
• Children under 2 years of age: ask a doctor
• To apply to face, spray on palm of hand and gently apply
Inactive Ingredients
Water, Glycerin, Propanediol, Aloe Barbadensis Leaf Juice,
Carbomer, Tocopheryl Acetate, PEG-40 Hydrogenated Castor Oil,
Sodium Lauroyl Sarcosinate, Disodium EDTA, Phenoxyethanol,
Sodium Hydroxide
Questions Or Comments?
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
www.valuelabels.com
800-715-3485
Principal Display Panel
GoodSense
Burn Relief
Continuous Spray
Topical Analgesic
With LidocainepROVIDES FAST RELIEF FROM:
- Sunburn
- Cuts & scrapes
- Insect bites,
- Minor burn & sunburn
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NET WT 6 OZ (170 g)
* Please review the disclaimer below.
