TEA TREE ANTISEPTIC CREAM- melaleuca alternifolia (tea tree) leaf oil cream 
Integria Healthcare (Australia) Pty. Ltd.

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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Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

Antiseptic

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

For external use only.

Do not

  • use near the eyes, mouth, ears or other sensitive areas of the body or apply over large areas of the body
  • longer than 1 week unless directed by a doctor.

Ask your 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 gets worse.

Keep out of reach of children.  If swallowed, get mecial help or contact a Poison Control Center right away.

It is recommended you skin patch test prior to use.

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage.

  • store below 86F/30C.
  • Do not use if plastic seal around cap is broken or missing

Bentonite, Cetyl Alcohol, Citric Acid, Glycerin, Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Sodium Hydroxymethylglycinate, Sodium Stearoyl Lactylate, Water, Xanthan Gum.

MADE IN AUSTRALIA

Manufactured for: Integria Healthcare (Australia) Pty Ltd.,

Building 5, Freeway Office Park, 2728 Logan Road,

Eight Mile Plains, QLD 4113 Australia

us.thursdayplantation.com

Questions or Comments?

1-877-428-2567

Best Before and Batch # stamped in tube seal

NDC 70446-643-50

Thursday

Plantation

Australia's Original

TEA TREE

ANTISEPTIC

CREAM

Gently soothes and relieves minor skin irritations

Net wt.

3.5 oz/100g

TeaTreeCream

TEA TREE ANTISEPTIC CREAM 
melaleuca alternifolia (tea tree) leaf oil cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70446-643
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MACADAMIA OIL (UNII: 515610SU8C)  
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70446-643-50100 g in 1 TUBE; Type 0: Not a Combination Product08/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/18/201607/13/2020
Labeler - Integria Healthcare (Australia) Pty. Ltd. (741396386)
Establishment
NameAddressID/FEIBusiness Operations
Tismor Health & Wellness Pty Ltd757701409manufacture(70446-643)

Revised: 7/2020
Document Id: aa5a7928-f9c6-813a-e053-2a95a90ae339
Set id: c2284306-b740-49a3-90f9-3ec960321c81
Version: 6
Effective Time: 20200713
 
Integria Healthcare (Australia) Pty. Ltd.