Antibacterial free gel

Manufacturer
Guangzhou Xin Qi Cosmetics Co., Ltd.
Effective date
2020-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:36

Label at a glance#

ProductAntibacterial free 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) (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. WATER
  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

WATER
CARBOMER
TRIETHANOLAMINE

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
78370-101-012021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-022021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-032021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-042021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-052021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-062021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-072021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-082021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-092021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-102021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-112021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-122021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-132021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-142021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-152021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-162021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-172021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-182021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-192021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-202021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel
78370-101-212021-07-23C16284748780-1c7ccaba7-17c4-fd44-e053-dadaa90aa01bAntibacterial free gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78370-101-01Antibacterial free gel60 mL in 1 BOTTLELIQUID601
78370-101-02Antibacterial free gel80 mL in 1 BOTTLELIQUID801
78370-101-03Antibacterial free gel100 mL in 1 BOTTLELIQUID1001
78370-101-04Antibacterial free gel200 mL in 1 BOTTLELIQUID2001
78370-101-05Antibacterial free gel250 mL in 1 BOTTLELIQUID2501
78370-101-06Antibacterial free gel300 mL in 1 BOTTLELIQUID3001
78370-101-07Antibacterial free gel500 mL in 1 BOTTLELIQUID5001
78370-101-08Antibacterial free gel1000 mL in 1 BOTTLELIQUID10001
78370-101-09Antibacterial free gel5000 mL in 1 BOTTLELIQUID50001
78370-101-10Antibacterial free gel10000 mL in 1 BOTTLELIQUID100001
78370-101-11Antibacterial free gel4000 mL in 1 BOTTLELIQUID40001
78370-101-12Antibacterial free gel2000 mL in 1 BOTTLELIQUID20001
78370-101-13Antibacterial free gel1500 mL in 1 BOTTLELIQUID15001
78370-101-14Antibacterial free gel236 mL in 1 BOTTLELIQUID2361
78370-101-15Antibacterial free gel240 mL in 1 BOTTLELIQUID2401
78370-101-16Antibacterial free gel30 mL in 1 BOTTLELIQUID301
78370-101-17Antibacterial free gel3800 mL in 1 BOTTLELIQUID38001
78370-101-18Antibacterial free gel5 mL in 1 BOTTLELIQUID51
78370-101-19Antibacterial free gel8 mL in 1 BOTTLELIQUID81
78370-101-20Antibacterial free gel50 mL in 1 BOTTLELIQUID501
78370-101-21Antibacterial free gel3 mL in 1 BOTTLELIQUID31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78370-101ANTIBACTERIAL FREE GEL (ALCOHOL) LIQUID [GUANGZHOU XIN QI COSMETICS CO., LTD.]1Legacy NDC, 21 package rows20200526_a679b333-c083-c796-e053-2a95a90aba80.zip

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
a679a79b-2b82-09c1-e053-2995a90a50b9a679b333-c083-c796-e053-2a95a90aba802020-05-25WarningsExact identifier
spl id: a679a79b-2b82-09c1-e053-2995a90a50b9
spl set id: a679b333-c083-c796-e053-2a95a90aba80

Reported adverse events (FAERS/openFDA)#

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