FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Sell-Able LLC
Effective date
2020-05-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:15:28

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Receive a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands Rub hands together until dry.

Storage and handling

Store in a cool dry place below 104 degress F (40C)

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

BENZALKONIUM CHLORIDE .12 g/100mL

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. Helps to prevent cross-contamination

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not use in or near eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop.

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 immediately.

Other information

STORAGE AND HANDLING SECTION

  • Store in a cool dry place below 104 degress F (40C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLOXAMER 124 (UNII: 1S66E28KXA)
D&C GREEN NO. 8 (UNII: I2W85YOX9L)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Receive a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together until dry.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

008008

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75094-007-072022-01-28C16284748780-1d6a99b39-3e33-a426-e053-dadaa90af4c2a31b38b6-0cf7-5734-e053-2995a90add41
75094-007-082022-01-28C16284748780-1d6a99b39-3e33-a426-e053-dadaa90af4c2a31b38b6-0cf7-5734-e053-2995a90add41

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75094-007-07Hand Sanitizer15 mL in 1 BOTTLE, SPRAYSPRAY153
75094-007-08Hand Sanitizer15 mL in 1 BOTTLE, SPRAYSPRAY153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75094-007HAND SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [SELL-ABLE LLC]3Legacy NDC, 2 package rows20200601_a31b38b6-0cf7-5734-e053-2995a90add41.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75094-00775094-007-07, 75094-007-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEHYDROACETIC ACID2KAG279R6RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
D&C GREEN NO. 8I2W85YOX9LIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLOXAMER 1241S66E28KXAIACT

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
a6fab856-888a-3885-e053-2a95a90a4e78a31b38b6-0cf7-5734-e053-2995a90add412020-05-31WarningsExact identifier
spl id: a6fab856-888a-3885-e053-2a95a90a4e78
spl set id: a31b38b6-0cf7-5734-e053-2995a90add41

Reported adverse events (FAERS/openFDA)#

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