FDA.reportPublic FDA data

reEarth Hand Sanitizer wipe

Manufacturer
NuGenTec
Effective date
2020-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:39

Label at a glance#

ProductreEarth Hand Sanitizer wipe
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Wet hands thoroughly with the product to cover all surfaces. Allow to dry without wiping. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 0-40C (32-104F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer, Antibacterial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with the product to cover all surfaces. Allow to dry without wiping.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 0-40C (32-104F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160 in Canister NDC: 77368-011-20 ReEarthLabelReEarthLabel ReEarthLabel Front and BackReEarthLabel Front and Back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77368-011-102022-01-28C16284748780-1c7ccaba7-2706-fd44-e053-dadaa90aa01bre:earth wipe Hand Sanitizer
77368-011-162022-01-28C16284748780-1c7ccaba7-2706-fd44-e053-dadaa90aa01bre:earth wipe Hand Sanitizer
77368-011-102021-09-23C16284748780-1c7ccaba7-2706-fd44-e053-dadaa90aa01bre:earth wipe Hand Sanitizer
77368-011-162021-09-23C16284748780-1c7ccaba7-2706-fd44-e053-dadaa90aa01bre:earth wipe Hand Sanitizer
77368-011-102021-07-23C16284748780-1c7ccaba7-2706-fd44-e053-dadaa90aa01bre:earth wipe Hand Sanitizer
77368-011-162021-07-23C16284748780-1c7ccaba7-2706-fd44-e053-dadaa90aa01bre:earth wipe Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77368-011-10reEarth Hand Sanitizer wipe100 in 1 CANISTERCLOTH1003
77368-011-10reEarth Hand Sanitizer wipe475 mL in 1 PACKAGECLOTH4753
77368-011-16reEarth Hand Sanitizer wipe160 in 1 CANISTERCLOTH1603
77368-011-16reEarth Hand Sanitizer wipe560 mL in 1 PACKAGECLOTH5603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77368-011REEARTH HAND SANITIZER WIPE (BENZALKONIUM CHLORIDE ) CLOTH [NUGENTEC]3Legacy NDC, 4 package rows20201015_b18503af-0d88-0864-e053-2a95a90abfc8.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77368-01177368-011-10, 77368-011-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
b1aa20d6-24f4-bd77-e053-2a95a90aa1a2b18503af-0d88-0864-e053-2a95a90abfc82020-10-14WarningsExact identifier
spl id: b1aa20d6-24f4-bd77-e053-2a95a90aa1a2
spl set id: b18503af-0d88-0864-e053-2a95a90abfc8

Reported adverse events (FAERS/openFDA)#

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