BOTANIKA AUSTRALIA TEA TREE ANTI BACTERIAL HAND SANITIZER- alcohol gel

Botanika Australia Tea Tree Anti Bacterial Hand Sanitizer by

Drug Labeling and Warnings

Botanika Australia Tea Tree Anti Bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by COGNESCENTI PTY. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

SD Alcohol 40-B 75% v/v

Purpose

Antiseptic

USE

• hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from fire and flame.

When using this product

avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation and redness develops.

Keep out of reach of children.

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

Directions

• Put enough on you palm to cover hands. Rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.

Other information:

• Store at 20℃ to 25℃ (68℉ to 77℉).
• May discolor some fabrics or surface.

Inactive ingredients

Purified Water (Aqua), Cross Polymer, Triethanolamine, Melaleuca Alternafolia (Tea tree) Leaf Oil, d-Limonene, Hydroxy-citronellal

package

INGREDIENTS AND APPEARANCE

BOTANIKA AUSTRALIA TEA TREE ANTI BACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79978-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79978-008-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/28/2020

Labeler - COGNESCENTI PTY. LTD. (745278551)

Establishment
Name	Address	ID/FEI	Business Operations
COGNESCENTI PTY. LTD.		745278551	manufacture(79978-008)