FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
CUSTOM RESEARCH LABS INC
Effective date
2022-03-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:04:50

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure9 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.

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT

  • KEEP OUT OF EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER.
  • AVOID CONTACT WITH BROKEN SKIN
  • DO NOT INHALE OR INHEST

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

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

WATER, GLYCERIN, ISOPROPYL MYRISTATE, CARBOMER, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Strd Issue Hand Sanitizer label revisedStrd Issue Hand Sanitizer label revised

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50518-303-112024-01-30C16284748780-11030e365-37f1-111a-e063-dadaa90a10e2CRL (as CMO) - STND. ISSUE HAND SANITIZER (50518-303)
50518-303-122024-01-30C16284748780-11030e365-37f1-111a-e063-dadaa90a10e2CRL (as CMO) - STND. ISSUE HAND SANITIZER (50518-303)

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
50518-30350518-303-11, 50518-303-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
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
db6517d2-2f14-9eb1-e053-2a95a90ab868ed84e1cf-cd54-446c-bb11-3ac975b9093b2022-03-29WarningsExact identifier
spl id: db6517d2-2f14-9eb1-e053-2a95a90ab868
spl set id: ed84e1cf-cd54-446c-bb11-3ac975b9093b

Reported adverse events (FAERS/openFDA)#

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