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Drug Facts
- Do not store at extreme temperatures.
Burnaid Burn Gel
FDA Label NDC 51121-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clear Healthcare Llc for the product Burnaid Burn Gel (NDC 51121-035). 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 other, active ingredient, purpose, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Meleleuca Oil 10mg/g
Purpose
For the first aid treatment of minor burns, scalds and sunburn.
Otc - Do Not Use
- Do not use on serious burns.
Otc - When Using
- FOR EXTERNAL USE ONLY.
Otc - Stop Use
- Discontinue use if irritation occurs.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. If
- swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Purified Water, Propylene Glycol, PEG 7 Glyceryl Cocoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Lactic Acid, Parabens
Directions
Figure (Burnaid 01)
1. Tear open sachet. 2. Apply gel liberally to affected area. Do not rub in. 3. Cover if necessary.
4. Seek medical attention if pain persists.
Principal Display Panel - 3.5 G Packet Label
NDC 51121-035-12
Burnaid®
BURN GEL
For first aid use on minor
burns, scalds and sunburn
- Cools
- Soothes
1/8 OZ. (3.5g)
SINGLE USE ONLY. DISCARD AFTER USE.
IF PACK HAS BEEN DAMAGED DO NOT USE.
Principal Display Panel (3.5 g Packet Label)
* Please review the disclaimer below.
