BURNAID BURN GEL- tea tree oil gel 
Clear Healthcare LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Burnaid® Burn Gel

Drug Facts

Active ingredient

Meleleuca Oil 10mg/g

Purpose

For the first aid treatment of minor burns, scalds and sunburn.

Warning

  • Do not use on serious burns.

  • FOR EXTERNAL USE ONLY.

  • Discontinue use if irritation occurs.

  • Do not store at extreme temperatures.

  • 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

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

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
BURNAID BURN GEL 
tea tree oil gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51121-035
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tea Tree Oil (UNII: VIF565UC2G) (Tea Tree Oil - UNII:VIF565UC2G) Tea Tree Oil 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
PEG-7 Glyceryl Cocoate (UNII: VNX7251543)  
Trolamine (UNII: 9O3K93S3TK)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Lactic Acid (UNII: 33X04XA5AT)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51121-035-12 3.5 g in 1 PACKET
2 NDC:51121-035-04 115 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/04/2013
Labeler - Clear Healthcare LLC (078886273)

Revised: 3/2014
Document Id: 6fcaf2ef-0976-4542-bb44-66f6c16e9568
Set id: a44e6c9f-02d0-4c70-9daa-759540ef9841
Version: 3
Effective Time: 20140319
 
Clear Healthcare LLC