FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Revler, Inc | Larry (Xiamen) Hi-Tech Co., Ltd.
Effective date
2020-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:56

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

• Apply enough product to thoroughly cover hands. Rub hands together until dry. • Apply enough product to thoroughly cover hands. Rub hands together until dry.

Storage and handling

Do not store above 110'F(43"C).

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)

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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. Glycerol
  3. Hydrogenated Castor Oil
  4. Sterile distilled water or boiled cold water.
  5. Carbomer
  6. Phenoxyethanol
  7. Benzyl Alcohol

  8. Sodium Hydroxide

  9. Fragrance (parfum)

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 70% 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

  • Do not use in 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

  • • Apply enough product to thoroughly cover hands. Rub hands together until dry.

RECENT MAJOR CHANGES SECTION

• Apply enough product to thoroughly cover hands. Rub hands together until dry.

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 110'F(43"C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua),Glycerin,PEG-40 Hydrogenated Castor Oil, Carbomer, Phenoxyethanol, Fragrance (parfum), Benzyl Alcohol ,Sodium Hydroxide

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ml label60 ml label60 mL NDC: 75257-170-06

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75257-170-062022-01-28C16284748780-1d6a99b39-5662-a426-e053-dadaa90af4c2a474360c-27b4-d93e-e053-2995a90a065c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75257-170-06Hand Sanitizer60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75257-170HAND SANITIZER (ALCOHOL) GEL [REVLER, INC]1Legacy NDC, 1 package rows20200430_a474360c-27b4-d93e-e053-2995a90a065c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75257-17075257-170-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CARBOMER 1342809Y72KV36IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
BENZYL ALCOHOLLKG8494WBHIACT

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
a4743673-812e-4732-e053-2995a90a22f2a474360c-27b4-d93e-e053-2995a90a065c2020-04-29WarningsExact identifier
spl id: a4743673-812e-4732-e053-2995a90a22f2
spl set id: a474360c-27b4-d93e-e053-2995a90a065c

Reported adverse events (FAERS/openFDA)#

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