FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Medline Industries, LP
Effective date
2026-02-11
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:43:53

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

to decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only: hands

Flammable. keep away from heat or flame.

When using this product

OTC - DO NOT USE SECTION

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation or redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants

Other information

OTHER SAFETY INFORMATION

  • do not store above 105°F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, diisopropylamine, glycerin, isopropyl myristate, tocopheryl acetate, water

Manufacturing Information

SPL UNCLASSIFIED SECTION

www.medline.com

©2023 Medline Industries, LP.

Medline is a registered trademark of Medline Industries, LP.

Spectrum is a trademark of Medline Industries, LP.

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials.

1-800-MEDLINE

REF: HH701200G

Directions

RECENT MAJOR CHANGES SECTION

Added in missing direction for use found on current labeling.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front Label V2 RB23VJOFront Label V2 RB23VJO

Back Label V2 RB23VJOBack Label V2 RB23VJO

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN11
581662ethanol 0.7 ML/ML Topical GelSCD11
581662ethanol 70 % Topical GelSY11
581662ethyl alcohol 70 % Topical GelSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-202-04Hand Sanitizer118 mL in 1 BOTTLEGEL11811
53329-202-08Hand Sanitizer236 mL in 1 BOTTLEGEL23611
53329-202-13Hand Sanitizer59 mL in 1 BOTTLEGEL5911
53329-202-70Hand Sanitizer443 mL in 1 BOTTLEGEL44311
53329-202-74Hand Sanitizer1200 mL in 1 BOTTLEGEL120011
53329-202-84Hand Sanitizer1000 mL in 1 BAGGEL100011
53329-202-85Hand Sanitizer354 mL in 1 BOTTLEGEL35411

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV361
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-20253329-202-13, 53329-202-04, 53329-202-08, 53329-202-70, 53329-202-84, 53329-202-85, 53329-202-74

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
DIISOPROPYLAMINEBR9JLI40NOIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-11-04monthly-update2026-06-03 17:38:48
92024-05-29full-release2026-06-01 00:13:08

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates

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
Hand SanitizerETHYL ALCOHOLMedline Industries, LPf84f7050-348d-4f75-ab93-e618ff8de7902026-02-11WarningsExact identifier
ndc (package): 53329-202-13
ndc (package): 53329-202-84
ndc (package): 53329-202-85
ndc (package): 53329-202-74
ndc (package): 53329-202-70
ndc (package): 53329-202-08
ndc (package): 53329-202-04
ndc (product): 53329-202
ndc11 (package): 53329020285
ndc11 (package): 53329020284
ndc11 (package): 53329020213
ndc11 (package): 53329020274
ndc11 (package): 53329020204
ndc11 (package): 53329020208
ndc11 (package): 53329020270
spl id: 4a8e1ef2-4cd3-a9a9-e063-6394a90a3990
spl set id: f84f7050-348d-4f75-ab93-e618ff8de790

Reported adverse events (FAERS/openFDA)#

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