FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
ABSOLUTE MARKETING, INC. | Beaming White LLC
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:19

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Dispense a small amount onto palm of hand and rub briskly and thoroughly over surfaces of both hands until dry. Children under 6 years of age should be supervised while using this product.

Storage and handling

Store below 110 °F (43 °C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic PDP 78389-003-99 APDP 78389-003-99 A

Purpose

OTC - PURPOSE SECTION

Antiseptic PDP 78389-003-99 BPDP 78389-003-99 B

Use

INDICATIONS & USAGE SECTION

PDP 78389-003-99 CPDP 78389-003-99 CHand Sanitizer to reduce bacterial organisms on the skin.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, flush eyes throughly with water.


Stop use and ask a doctor if irritation or rash develops and persists. T

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash develops and persists.

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

  • Dispense a small amount onto palm of hand and rub briskly and thoroughly over surfaces of both hands until dry.
  • Children under 6 years of age should be supervised while using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110 °F (43 °C)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Triethanolamine

PDP 78389-003-99

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BW PL Label 78389-003-99 PDPBW PL Label 78389-003-99 PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78389-003-992022-01-28C16284748780-1d6a99b39-3f7e-a426-e053-dadaa90af4c2a75ae4d6-21d3-54a4-e053-2a95a90af11a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78389-003-99Hand Sanitizer3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78389-003HAND SANITIZER (ALCOHOL) GEL [ABSOLUTE MARKETING, INC.]1Legacy NDC, 1 package rows20200612_a75ae4d6-21d3-54a4-e053-2a95a90af11a.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78389-00378389-003-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a75ae4d6-21d4-54a4-e053-2a95a90af11aa75ae4d6-21d3-54a4-e053-2a95a90af11a2020-06-05WarningsExact identifier
spl id: a75ae4d6-21d4-54a4-e053-2a95a90af11a
spl set id: a75ae4d6-21d3-54a4-e053-2a95a90af11a

Reported adverse events (FAERS/openFDA)#

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