TERRANEA CARES WELLNESS KIT- alcohol kit

Terranea Cares Wellness Kit by

Drug Labeling and Warnings

Terranea Cares Wellness Kit by is a Otc medication manufactured, distributed, or labeled by Buzz Export Services Pty., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl Alcohol 75% (v/v)

Purpose

Antiseptic

Uses

To help reduce bacteria on the skin.

Warnings

• For external use only.
• Flammable. Keep away from fire or flame.

When using this product

• avoid contact with eyes.
• if contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

• Squeeze a significant amount in your palm and rub hands until full dry. No rinsing required.

Other Information

• Store below 110°f (43°C).

Inactive ingredients

Water (Aqua), Glycerin, Acrylates/C-10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aminomethyl Propanol.

Drug Facts

Active Ingredient

Ethyl Alcohol 75% (v/v)

Purpose

Antiseptic

Uses

• To help reduce bacteria on the skin.

Warnings

• For external use only.
• Do not dispose of wipes in flush toilets.

Flammable

• Keep away from fire or flame.

When using this product

• avoid contact with eyes.
• if contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if

• irritation or redness develops and lasts.

Keep out of reach of children

• In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

Apply to hands or surfaces.
No rinsing required.
Discard after use.

Other Information

• Store below 110°F (43°C).
• May discolor certain fabrics or surfaces.

Inactive ingredients

Aqua (Water), Glycerin. Polyquaternium-37, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

Kit Label:

Package Labeling:69491-301-00

Package Labeling:69491-303-00

INGREDIENTS AND APPEARANCE

TERRANEA CARES WELLNESS KIT 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69491-304

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-304-00	1 in 1 KIT	09/30/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	20 mL
Part 2	1 PATCH	5 mL

Part 1 of 2

HAND SANITIZER WITH TEA TREE OIL 75% ALCOHOL 
alcohol gel

Product Information
Item Code (Source)	NDC: 69491-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-301-00	20 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/30/2020

Part 2 of 2

MURCHISON-HUME SANITIZING WIPE WITH TEA TREE OIL 75% ALCOHOL 
alcohol cloth

Product Information
Item Code (Source)	NDC: 69491-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-303-00	1 in 1 PACKAGE
1		5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/30/2020

Labeler - Buzz Export Services Pty., Ltd. (747317902)