Your browser does not support JavaScript! BURNAID BURN GEL (TEA TREE OIL) GEL [CLEAR HEALTHCARE LLC]
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BURNAID BURN GEL (tea tree oil) gel
[Clear Healthcare LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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

  • 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
BURNAID BURN GEL 
tea tree oil gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51121-035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tea Tree Oil (Tea Tree Oil) Tea Tree Oil10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Propylene Glycol 
PEG-7 Glyceryl Cocoate 
Trolamine 
.Alpha.-Tocopherol Acetate 
Lactic Acid 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51121-035-123.5 g in 1 PACKET
2NDC:51121-035-04115 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/04/2013
Labeler - Clear Healthcare LLC (078886273)

Revised: 3/2014
 
Clear Healthcare LLC

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