FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
GUILIN LIFENG MEDICAL SUPPLIES CO.,LTD.
Effective date
2021-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:24

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry withuot wiping. 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. Ethyl 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 (1.45% v/v).
  3. Moisture Complex.
  4. Herbal Essence (0.125% v/v).
  5. Carbopol
  6. Fragrance

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 decrease bacteria on the skin that may cause disease.

Warnings

WARNINGS SECTION

For external use only: hands or skin surface

Flammable, keep away from fire or flame

Caution for those who are allergic to alcohol

Do not use

OTC - DO NOT USE SECTION

  • For infants or young children (under 6) without supervision
  • When you are allergic to alcohol

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

  • Wet hands thoroughly with product and allow to dry withuot wiping.
  • 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, Moisture Complex, Herbal Essence, Carbopol, Fragrance

Package Label - Principal Display Pane

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 L label2 L label236 ml label236 ml label60 ml Label60 ml Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81898-103-102022-07-29C16284748780-1e4f33bdf-adce-d8a0-e053-dadaa90a6e4eHand Sanitizer Gel
81898-103-112022-07-29C16284748780-1e4f33bdf-adce-d8a0-e053-dadaa90a6e4eHand Sanitizer Gel
81898-103-122022-07-29C16284748780-1e4f33bdf-adce-d8a0-e053-dadaa90a6e4eHand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81898-103-10Hand Sanitizer60 mL in 1 BOTTLEGEL601
81898-103-11Hand Sanitizer236 mL in 1 BOTTLEGEL2361
81898-103-12Hand Sanitizer2000 mL in 1 BOTTLEGEL20001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81898-103HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [GUILIN LIFENG MEDICAL SUPPLIES CO.,LTD.]1Legacy NDC, 3 package rows20210518_c28f16a4-ec85-53ce-e053-2995a90a636e.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
81898-10381898-103-10, 81898-103-11, 81898-103-12

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
c28f16a4-ec84-53ce-e053-2995a90a636ec28f16a4-ec85-53ce-e053-2995a90a636e2021-05-17WarningsExact identifier
spl id: c28f16a4-ec84-53ce-e053-2995a90a636e
spl set id: c28f16a4-ec85-53ce-e053-2995a90a636e

Reported adverse events (FAERS/openFDA)#

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