FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Reneotech Inc | Shantou Kangjie Daily Chemical Industry Co., Ltd
Effective date
2020-08-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:20

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Directions Wet hands thoroughly with product and allow to dry without wiping For Children under 6, use only under adult supervision Not recommended for infants

Storage and handling

Do not store above 105°F May discolor some fabrics Harmful to woodfinishes and plastics

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. 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

Ethlyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Uses

  • To decrease bacteria on the skin that could cause disease
  • Recommended for repeat use

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire 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, incased of contact with eyes, flush thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Irritation and redness develop
  • Condition persists for more than 72 hours

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

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
  • For Children under 6, use only under adult supervision
  • Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 105°F
  • May discolor some fabrics
  • Harmful to woodfinishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Polyacrylic Acid, Wormwood Leaf Extract, Dandelion Extract, Aminomethyl Propanol.

RECENT MAJOR CHANGES SECTION

  • usage
  • warnings

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • 59.1471 ml NDC: 79991-001-05
  • Front Label of 2ozFront Label of 2oz
  • Back Label of 2ozBack Label of 2oz
  • 236.588 ml NDC: 79991-001-08
  • Front Label of 8ozFront Label of 8oz
  • Front Label of 8ozFront Label of 8oz
  • 480 ml NDC: 79991-001-10
  • 480 ml Front480 ml Front
  • 480 ml Back480 ml Back
  • 946.353 ml NDC: 79991-001-12
  • Front and Back of 32ozFront and Back of 32oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79991-001-052022-01-28C16284748780-1d6a99b39-fa3f-a426-e053-dadaa90af4c2Handsanitizer
79991-001-082022-01-28C16284748780-1d6a99b39-fa3f-a426-e053-dadaa90af4c2Handsanitizer
79991-001-102022-01-28C16284748780-1d6a99b39-fa3f-a426-e053-dadaa90af4c2Handsanitizer
79991-001-122022-01-28C16284748780-1d6a99b39-fa3f-a426-e053-dadaa90af4c2Handsanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79991-001-05Hand Sanitizer59.1471 mL in 1 BOTTLEGEL59.14712
79991-001-08Hand Sanitizer236.588 mL in 1 BOTTLEGEL236.5882
79991-001-10Hand Sanitizer473.176 mL in 1 BOTTLEGEL473.1762
79991-001-12Hand Sanitizer946.353 mL in 1 BOTTLEGEL946.3532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79991-001HAND SANITIZER (ETHYL ALCOHOL) GEL [RENEOTECH INC]2Legacy NDC, 4 package rows20200821_abbe5fff-8cc9-0565-e053-2a95a90a5604.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79991-00179991-001-08, 79991-001-12, 79991-001-05, 79991-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
WORMWOODF84709P2XVIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
TARAXACUM OFFICINALE ROOT9DE5YCO0RUIACT

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
ad50ece8-7189-1b8d-e053-2a95a90ac78babbe5fff-8cc9-0565-e053-2a95a90a56042020-08-20WarningsExact identifier
spl id: ad50ece8-7189-1b8d-e053-2a95a90ac78b
spl set id: abbe5fff-8cc9-0565-e053-2a95a90a5604

Reported adverse events (FAERS/openFDA)#

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