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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Tea Tree Oil (UNII: VIF565UC2G) (Tea Tree Oil - UNII:VIF565UC2G)	Tea Tree Oil	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:51121-035-12	3.5 g in 1 PACKET
2	NDC:51121-035-04	115 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		11/04/2013