FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:03

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Reduce bacteria on the skin. Recommended for repeated use

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Children under 6 years of age should be supervised by an adult when applying this product

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire, flame, or sparks

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 appears on the skin.

Uses

INDICATIONS & USAGE SECTION

  • Reduce bacteria on the skin.
  • Recommended for repeated use

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Children under 6 years of age should be supervised by an adult when applying this product

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

Other informatio

SPL UNCLASSIFIED SECTION

  • Store between 15-30C (59-86F)
  • May discolor certain fabrics or surfaces

Inactive Ingredient

INACTIVE INGREDIENT SECTION


Alpha-Tocopherol, glycerin, hydrogen peroxide, purified water USP

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-850-022022-01-28C16284748780-1d6a99b39-3ff5-a426-e053-dadaa90af4c2HAND SANITIZER
13411-850-082022-01-28C16284748780-1d6a99b39-3ff5-a426-e053-dadaa90af4c2HAND SANITIZER
13411-850-162022-01-28C16284748780-1d6a99b39-3ff5-a426-e053-dadaa90af4c2HAND SANITIZER
13411-850-372022-01-28C16284748780-1d6a99b39-3ff5-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-850-02HAND SANITIZER60 mL in 1 BOTTLE, DISPENSINGLIQUID601
13411-850-08HAND SANITIZER236 mL in 1 BOTTLE, DISPENSINGLIQUID2361
13411-850-16HAND SANITIZER473 mL in 1 BOTTLE, DISPENSINGLIQUID4731
13411-850-37HAND SANITIZER3780 mL in 1 BOTTLE, DISPENSINGLIQUID37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-850HAND SANITIZER (ALCOHOL) LIQUID [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 4 package rows20200618_90294780-26da-4f75-aff7-5bcedcc18b24.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
13411-85013411-850-02, 13411-850-08, 13411-850-16, 13411-850-37

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
ALCOHOL3K9958V90MACTIB
Alpha-TocopherolH4N855PNZ1IACT
GlycerinPDC6A3C0OXIACT
Hydrogen PeroxideBBX060AN9VIACT
Water059QF0KO0RIACT

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
0eb547df-3588-4cb3-9e46-9e72dabc5d4d90294780-26da-4f75-aff7-5bcedcc18b242020-05-20WarningsExact identifier
spl id: 0eb547df-3588-4cb3-9e46-9e72dabc5d4d
spl set id: 90294780-26da-4f75-aff7-5bcedcc18b24

Reported adverse events (FAERS/openFDA)#

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