BURNAID BURN GEL- tea tree oil gel

Burnaid Burn Gel by

Drug Labeling and Warnings

Burnaid Burn Gel by is a Otc medication manufactured, distributed, or labeled by Clear Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Meleleuca Oil 10mg/g

PURPOSE

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

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.

INGREDIENTS AND APPEARANCE

BURNAID BURN GEL 
tea tree oil gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51121-035
Route of Administration	TOPICAL

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)