FDA.reportPublic FDA data

Terranea Cares Wellness Kit

Manufacturer
Buzz Export Services Pty., Ltd.
Effective date
2022-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:17

Label at a glance#

ProductTerranea Cares Wellness Kit
Active ingredientALCOHOL
Label structure15 sections

Indications and uses

To help reduce bacteria on the skin.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop using and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develops and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

  • Store below 110°f (43°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • To help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

Flammable

  • Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

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

Stop using and ask a doctor if

OTC - STOP USE SECTION

  • irritation or redness develops and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Kit Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KITKIT

Package Labeling:69491-301-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.Label.

Package Labeling:69491-303-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN2
1305100ethanol 75 % Topical GelPSN2
1307051ethanol 0.75 ML/ML Medicated PadSCD2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1307051ethanol 75 % Hand Sanitizer WipesSY2
1305100ethanol 75 % Topical GelSY2
1307051ethyl alcohol 75 % Topical ClothSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69491-304-002024-01-30C16284748780-1d6a99b39-6183-a426-e053-dadaa90af4c2Terranea Cares Wellness Kit
69491-304-002022-02-16C16284748780-1d6a99b39-6183-a426-e053-dadaa90af4c2Terranea Cares Wellness Kit
69491-304-002022-01-28C16284748780-1d6a99b39-6183-a426-e053-dadaa90af4c2Terranea Cares Wellness Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69491-301-00Terranea Cares Wellness Kit20 mL in 1 BOTTLEGEL20 mL0.75 mL in 1mL2
69491-303-00Terranea Cares Wellness Kit1 in 1 PACKAGECLOTH0.75 mL in 1mL2
69491-303-00Terranea Cares Wellness Kit5 mL in 1 PATCHCLOTH5 mL0.75 mL in 1mL2
69491-304-00Terranea Cares Wellness Kit1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69491-301TERRANEA CARES WELLNESS KIT (ALCOHOL) KIT [BUZZ EXPORT SERVICES PTY., LTD.]2Unmatched20220217_af092aa3-d310-4046-e053-2995a90ae2d9.zip
69491-303TERRANEA CARES WELLNESS KIT (ALCOHOL) KIT [BUZZ EXPORT SERVICES PTY., LTD.]2Unmatched20220217_af092aa3-d310-4046-e053-2995a90ae2d9.zip
69491-304TERRANEA CARES WELLNESS KIT (ALCOHOL) KIT [BUZZ EXPORT SERVICES PTY., LTD.]2Legacy NDC, 4 package rows20220217_af092aa3-d310-4046-e053-2995a90ae2d9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69491-30469491-304-00
69491-30169491-301-00
69491-30369491-303-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6fa05fd-4fdb-6480-e053-2995a90a5156af092aa3-d310-4046-e053-2995a90ae2d92022-02-01WarningsExact identifier
spl id: d6fa05fd-4fdb-6480-e053-2995a90a5156
spl set id: af092aa3-d310-4046-e053-2995a90ae2d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.