FDA.reportPublic FDA data

Apple Foaming Hand Sanitizer

Manufacturer
Alpha Aromatics
Effective date
2022-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:25

Label at a glance#

ProductApple Foaming Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water USP, glycerin, PEG-10 dimethicone, fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 gallon NDC: 75009-662-01

3780ml label3780ml label

5 gallon NDC: 75009-662-02

18920ml label18920ml label

55 gallon NDC: 75009-662-03

208190ml label208190ml label

275 gallon NDC: 75009-662-04

1040980ml label1040980ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616763ethanol 62 % Topical FoamPSN2
616763ethanol 0.62 ML/ML Topical FoamSCD2
616763ethanol 62 % Topical FoamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75009-662-012024-01-30C16284748780-11030e365-366d-111a-e063-dadaa90a10e2APPLE FOAMING HAND SANITIZER 62%(V/V)
75009-662-022024-01-30C16284748780-11030e365-366d-111a-e063-dadaa90a10e2APPLE FOAMING HAND SANITIZER 62%(V/V)
75009-662-032024-01-30C16284748780-11030e365-366d-111a-e063-dadaa90a10e2APPLE FOAMING HAND SANITIZER 62%(V/V)
75009-662-042024-01-30C16284748780-11030e365-366d-111a-e063-dadaa90a10e2APPLE FOAMING HAND SANITIZER 62%(V/V)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75009-662-01Apple Foaming Hand Sanitizer3780 mL in 1 JUGLIQUID37802
75009-662-02Apple Foaming Hand Sanitizer18920 mL in 1 PAILLIQUID189202
75009-662-03Apple Foaming Hand Sanitizer208190 mL in 1 DRUMLIQUID2081902
75009-662-04Apple Foaming Hand Sanitizer1040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID10409802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75009-662APPLE FOAMING HAND SANITIZER LIQUID [ALPHA AROMATICS]2Legacy NDC, 4 package rows20220123_a97819da-eb13-719e-e053-2a95a90a72cf.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
75009-66275009-662-01, 75009-662-02, 75009-662-03, 75009-662-04

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
CYCLAMEN ALDEHYDE4U37UX0E1EIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE 200RGS4T2AS00IACT
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
d61e028c-1f5b-8d9d-e053-2995a90a1839a97819da-eb13-719e-e053-2a95a90a72cf2022-01-21WarningsExact identifier
spl id: d61e028c-1f5b-8d9d-e053-2995a90a1839
spl set id: a97819da-eb13-719e-e053-2a95a90a72cf

Reported adverse events (FAERS/openFDA)#

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