TERRANEA CARES WELLNESS KIT- alcohol 
Buzz Export Services Pty., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Terranea Cares Wellness Kit

Drug Facts

Active Ingredient

Ethyl Alcohol 75% (v/v)

Purpose

Antiseptic

Uses

To help reduce bacteria on the skin.

Warnings

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

Other Information

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

Warnings

Flammable

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

Inactive ingredients

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

Kit Label:

KIT

Package Labeling:69491-301-00

Label.

Package Labeling:69491-303-00

Label2

TERRANEA CARES WELLNESS KIT 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-304
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-304-001 in 1 KIT09/30/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 20 mL
Part 21 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-301-0020 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/30/2020
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-303-001 in 1 PACKAGE
15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/30/2020
Labeler - Buzz Export Services Pty., Ltd. (747317902)

Revised: 2/2022
Document Id: d6fa05fd-4fdb-6480-e053-2995a90a5156
Set id: af092aa3-d310-4046-e053-2995a90ae2d9
Version: 2
Effective Time: 20220201
 
Buzz Export Services Pty., Ltd.