FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
PrintJet Corp | Sue L Sotelo
Effective date
2020-04-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:26

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% 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

glycerin, hydrogen peroxide, purified water USP, Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 ml NDC: 76795-738-17

1 GAL SPRAY1 GAL SPRAY

946 ml NDC: 76795-738-16

946ML SPRAY946ML SPRAY

473 ml NDC: 76795-738-15

16 OZ SPRAY16 OZ SPRAY

237 ml NDC: 76795-738-14

8OZ SPRAY8OZ SPRAY

177 ml NDC: 76795-738-13

6OZ SPRAY6OZ SPRAY

118 ml NDC: 76795-737-12

118ML SPRAY118ML SPRAY

60 ml NDC: 76795-738-11

2OZ SPRAY2OZ SPRAY

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76795-738-112022-01-28C16284748780-1d6a99b39-ab2b-a426-e053-dadaa90af4c2a9cef3f8-fd91-9ccc-e053-2995a90a0a35
76795-738-122022-01-28C16284748780-1d6a99b39-ab2b-a426-e053-dadaa90af4c2a9cef3f8-fd91-9ccc-e053-2995a90a0a35
76795-738-132022-01-28C16284748780-1d6a99b39-ab2b-a426-e053-dadaa90af4c2a9cef3f8-fd91-9ccc-e053-2995a90a0a35
76795-738-142022-01-28C16284748780-1d6a99b39-ab2b-a426-e053-dadaa90af4c2a9cef3f8-fd91-9ccc-e053-2995a90a0a35
76795-738-152022-01-28C16284748780-1d6a99b39-ab2b-a426-e053-dadaa90af4c2a9cef3f8-fd91-9ccc-e053-2995a90a0a35
76795-738-162022-01-28C16284748780-1d6a99b39-ab2b-a426-e053-dadaa90af4c2a9cef3f8-fd91-9ccc-e053-2995a90a0a35
76795-738-172022-01-28C16284748780-1d6a99b39-ab2b-a426-e053-dadaa90af4c2a9cef3f8-fd91-9ccc-e053-2995a90a0a35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76795-738-11Hand Sanitizer60 mL in 1 BOTTLE, SPRAYSPRAY601
76795-738-12Hand Sanitizer118 mL in 1 BOTTLE, SPRAYSPRAY1181
76795-738-13Hand Sanitizer177 mL in 1 BOTTLE, SPRAYSPRAY1771
76795-738-14Hand Sanitizer237 mL in 1 BOTTLE, SPRAYSPRAY2371
76795-738-15Hand Sanitizer473 mL in 1 BOTTLE, SPRAYSPRAY4731
76795-738-16Hand Sanitizer946 mL in 1 BOTTLE, SPRAYSPRAY9461
76795-738-17Hand Sanitizer3785 mL in 1 BOTTLE, SPRAYSPRAY37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76795-738HAND SANITIZER (ALCOHOL) SPRAY [PRINTJET CORP]1Legacy NDC, 7 package rows20200708_a9cef3f8-fd91-9ccc-e053-2995a90a0a35.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
76795-73876795-738-11, 76795-738-12, 76795-738-13, 76795-738-14, 76795-738-15, 76795-738-16, 76795-738-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT

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
a9ce77cd-4471-db1b-e053-2a95a90ade03a9cef3f8-fd91-9ccc-e053-2995a90a0a352020-04-26WarningsExact identifier
spl id: a9ce77cd-4471-db1b-e053-2a95a90ade03
spl set id: a9cef3f8-fd91-9ccc-e053-2995a90a0a35

Reported adverse events (FAERS/openFDA)#

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