TEA TREE ANTISEPTIC  - tea tree oil ointment 
Integria Healthcare (US) Inc

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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Drug Facts

Active ingredient

Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

Purpose

First Aid Antiseptic

Uses

First aid to help protect against infection in minor cuts, scrapes and burns.

Warnings

For external use only

Do not Use

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns.

Stop use and ask a doctor if

condition persists or worsens.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Paraffin white soft, Mineral oil, Cetostearyl alcohol, dl-alpha tocopheryl acetate

DISTRIBUTED BY: Integria Healthcare (US) Inc., Paramount CA 90723-3426.

USA Health Food: Natural Organics Inc, 548 Broadhollow Road Melville NY 11747

MADE IN AUSTRALIA

Principal Display Panel

NDC 51257-642-02

Thursday Plantation

Australia's Original

TEA TREE ANTISEPTIC OINTMENT

First aid to help protect

against infection in minor

cuts, scrapes and burns

Net Wt 1.76 oz (50 g)


TT Antiseptic Ointment label



TEA TREE ANTISEPTIC  
tea tree oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51257-642
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51257-642-0250 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/27/2013
Labeler - Integria Healthcare (US) Inc (962379454)

Revised: 8/2013
Document Id: dee2c583-61d1-4b1c-955f-b9319b4e5df4
Set id: d0242327-a23a-4ae3-a131-11b0e601dbbf
Version: 2
Effective Time: 20130827
 
Integria Healthcare (US) Inc