Hand Sanitizer

Manufacturer
Henan Shizheng Pharmaceutical Technology Co., Ltd.
Effective date
2020-05-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:10:57

Label at a glance#

ProductAonisen Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Apply enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under age 6 should be supervised when using this product.

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. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerin (3% v/v).
  3. Carbomer (0.8% v/v).
  4. Trolamine(0.2% v/v).
  5. 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

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

FLAMMABLE. Keep away from fire and flames.

EXTERNAL USE ONLY.

Keep out of eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs and lasts.

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

Apply enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.

Children under age 6 should be supervised when using this product.

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

Water,Glycerin, Trolamine, Carbomer

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ml NDC: 75138-130-06 60mL Aonisen Label60mL Aonisen Label100 mL NDC: 75138-130-10 100 mL Aonisen Label100 mL Aonisen Label

300 mL NDC: 75138-130-30 300 mL Aonisen Label300 mL Aonisen Label

500 mL NDC: 75138-130-51 500mL Aonisen Label500mL Aonisen Label500 mL NDC: 75138-130-52 500 mL Aonisen Label500 mL Aonisen Label

30 ml NDC: 75138-130-13 30 mL Label30 mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75138-130-06Aonisen Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL592
75138-130-10Aonisen Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1002
75138-130-13Aonisen Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL302
75138-130-30Aonisen Hand Sanitizer300 mL in 1 BOTTLE, PUMPGEL3002
75138-130-51Aonisen Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002
75138-130-52Aonisen Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75138-130AONISEN HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [HENAN SHIZHENG PHARMACEUTICAL TECHNOLOGY CO., LTD.]2Legacy NDC, 6 package rows20200513_a2e46b9f-426b-52f1-e053-2995a90aa19c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75138-13075138-130-10, 75138-130-06, 75138-130-51, 75138-130-52, 75138-130-30, 75138-130-13

Ingredients#

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

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

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
a531eba5-c518-99e3-e053-2a95a90a27b0a2e46b9f-426b-52f1-e053-2995a90aa19c2020-05-09WarningsExact identifier
spl id: a531eba5-c518-99e3-e053-2a95a90a27b0
spl set id: a2e46b9f-426b-52f1-e053-2995a90aa19c

Reported adverse events (FAERS/openFDA)#

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