FDA.reportPublic FDA data

Antibacterial hand sanitizer gel

Manufacturer
Yaer Baizi Import and Export Trade (Guangzhou) Co., Ltd.
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:18

Label at a glance#

ProductAntibacterial hand sanitizer gel
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) (75%, 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. Aqua
  3. Carbomer
  4. triethanolamine

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

Aqua
Carbomer
triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5050989810010025025030030050050010001000

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75240-101-012021-07-23C16284748780-1c7ccaba7-2913-fd44-e053-dadaa90aa01bAntibacterial hand sanitizer gel
75240-101-022021-07-23C16284748780-1c7ccaba7-2913-fd44-e053-dadaa90aa01bAntibacterial hand sanitizer gel
75240-101-032021-07-23C16284748780-1c7ccaba7-2913-fd44-e053-dadaa90aa01bAntibacterial hand sanitizer gel
75240-101-042021-07-23C16284748780-1c7ccaba7-2913-fd44-e053-dadaa90aa01bAntibacterial hand sanitizer gel
75240-101-052021-07-23C16284748780-1c7ccaba7-2913-fd44-e053-dadaa90aa01bAntibacterial hand sanitizer gel
75240-101-062021-07-23C16284748780-1c7ccaba7-2913-fd44-e053-dadaa90aa01bAntibacterial hand sanitizer gel
75240-101-072021-07-23C16284748780-1c7ccaba7-2913-fd44-e053-dadaa90aa01bAntibacterial hand sanitizer gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75240-101-01Antibacterial hand sanitizer gel50 mL in 1 BOTTLELIQUID501
75240-101-02Antibacterial hand sanitizer gel98 mL in 1 BOTTLELIQUID981
75240-101-03Antibacterial hand sanitizer gel100 mL in 1 BOTTLELIQUID1001
75240-101-04Antibacterial hand sanitizer gel250 mL in 1 BOTTLELIQUID2501
75240-101-05Antibacterial hand sanitizer gel300 mL in 1 BOTTLELIQUID3001
75240-101-06Antibacterial hand sanitizer gel500 mL in 1 BOTTLELIQUID5001
75240-101-07Antibacterial hand sanitizer gel1000 mL in 1 BOTTLELIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75240-101ANTIBACTERIAL HAND SANITIZER GEL (ALCOHOL) LIQUID [YAER BAIZI IMPORT AND EXPORT TRADE (GUANGZHOU) CO., LTD.]1Legacy NDC, 7 package rows20200428_a446e6eb-14f4-fea9-e053-2a95a90aa08f.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75240-10175240-101-01, 75240-101-02, 75240-101-03, 75240-101-04, 75240-101-05, 75240-101-06, 75240-101-07

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
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
a446df28-2dc3-5b4b-e053-2995a90a7bf6a446e6eb-14f4-fea9-e053-2a95a90aa08f2020-04-27WarningsExact identifier
spl id: a446df28-2dc3-5b4b-e053-2995a90a7bf6
spl set id: a446e6eb-14f4-fea9-e053-2a95a90aa08f

Reported adverse events (FAERS/openFDA)#

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