FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Neptune Health & Wellness Innovation | Dimensional Merchandising Inc.
Effective date
2021-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:40

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer 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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bergamot Essential Oil, Fragrance (Essential Oil Blend), Organic Aloe barbadensis Leaf Juice, Organic Glycerin (Flax Seed), Purified Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 fl. oz. (60 mL) NDC: 79965-007-00

79965-007-0079965-007-00

4 fl. oz. (120 mL) NDC: 79965-007-01

79965-007-0179965-007-01

2 fl. oz. (60 mL) NDC: 79965-107-00

79965-107-0079965-107-00

4 fl. oz. (120 mL) NDC: 79965-107-01

79965-107-0179965-107-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902515ethanol 65 % Topical SprayPSN1
902515ethanol 0.65 ML/ML Topical SpraySCD1
902515ethanol 65 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79965-007-002023-01-30C16284748780-1f386c649-dcc1-0266-e053-dadaa90a7c1ac3b6e92c-4fac-719e-e053-2a95a90a710b
79965-007-012023-01-30C16284748780-1f386c649-dcc1-0266-e053-dadaa90a7c1ac3b6e92c-4fac-719e-e053-2a95a90a710b
79965-107-002023-01-30C16284748780-1f386c649-dcc1-0266-e053-dadaa90a7c1ac3b6e92c-4fac-719e-e053-2a95a90a710b
79965-107-012023-01-30C16284748780-1f386c649-dcc1-0266-e053-dadaa90a7c1ac3b6e92c-4fac-719e-e053-2a95a90a710b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79965-007-00Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID601
79965-007-01Hand Sanitizer120 mL in 1 BOTTLE, SPRAYLIQUID1201
79965-107-00Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID601
79965-107-01Hand Sanitizer120 mL in 1 BOTTLE, SPRAYLIQUID1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79965-007HAND SANITIZER (ALCOHOL) LIQUID [NEPTUNE HEALTH & WELLNESS INNOVATION]1Legacy NDC, 2 package rows20210602_c3b6e92c-4fac-719e-e053-2a95a90a710b.zip
79965-107HAND SANITIZER (ALCOHOL) LIQUID [NEPTUNE HEALTH & WELLNESS INNOVATION]1Legacy NDC, 2 package rows20210602_c3b6e92c-4fac-719e-e053-2a95a90a710b.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
79965-00779965-007-00, 79965-007-01
79965-10779965-107-00, 79965-107-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
BERGAMOT OIL39W1PKE3JIIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
BERGAMOT OIL39W1PKE3JIIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT

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
c3b693d4-8c1b-eede-e053-2a95a90ac373c3b6e92c-4fac-719e-e053-2a95a90a710b2021-06-01WarningsExact identifier
spl id: c3b693d4-8c1b-eede-e053-2a95a90ac373
spl set id: c3b6e92c-4fac-719e-e053-2a95a90a710b

Reported adverse events (FAERS/openFDA)#

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