FDA.reportPublic FDA data

FOAMING HAND SANITIZER

Manufacturer
APOLLO HEALTH AND BEAUTY CARE
Effective date
2010-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:07

Label at a glance#

ProductFOAMING HAND SANITIZER WITH ALOE
Active ingredientBENZALKONIUM CHLORIDE
Label structure4 sections

Indications and uses

USES: TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE. DIRECTIONS: PUMP DESIRED AMOUNT ONTO HANDS AND RUB UNTIL YOUR SKIN IS DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Dosage and administration

USES: TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE. DIRECTIONS: PUMP DESIRED AMOUNT ONTO HANDS AND RUB UNTIL YOUR SKIN IS DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE  0.1% (ANTISEPTIC)

USES AND DIRECTIONS

OTC - PURPOSE SECTION

  • USES: TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.
  • DIRECTIONS: PUMP DESIRED AMOUNT ONTO HANDS AND RUB UNTIL YOUR SKIN IS DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • SKIN IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

PACKAGE FRONT AND BACK LABELS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • 8OZ FRONT AND BACK LABELS: nc08.jpg8OZ FRONT AND BACK LABELS8OZ FRONT AND BACK LABELS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN1
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD1
1038799benzalkonium chloride 0.1 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-240-082020-01-31C16284748780-19d75b9d1-0a4d-f424-e053-dadaa90a57ceDRUG FACTS BOX (BACK LABEL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-240-08FOAMING HAND SANITIZERWITH ALOE236 mL in 1 BOTTLE, PUMPLIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-240FOAMING HAND SANITIZER WITH ALOE (BENZALKONIUM CHLORIDE) LIQUID [APOLLO HEALTH AND BEAUTY CARE]1Legacy NDC, 1 package rows20100710_1e751e6a-d6fc-4cbc-8d9a-60bfd23e10b7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-24063148-240-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
b035432f-f0d7-42d5-b132-2e4fb26740321e751e6a-d6fc-4cbc-8d9a-60bfd23e10b72010-06-25WarningsExact identifier
spl id: b035432f-f0d7-42d5-b132-2e4fb2674032
spl set id: 1e751e6a-d6fc-4cbc-8d9a-60bfd23e10b7

Reported adverse events (FAERS/openFDA)#

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