FDA.reportPublic FDA data

AFFEX Hand Sanitizer

Manufacturer
Autotrol Corporation
Effective date
2021-12-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:45:26

Label at a glance#

ProductAFFEX Care Ultra Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Flammable. Keep away from heat or flame

For external use only.

INSTRUCTIONS FOR USE SECTION

place enough product in your palm to thoroughly cover your hands
rub hands together briskly until dry
children under 6 years of age should be supervised when using this product

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.

OTHER SAFETY INFORMATION

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

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.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a physician if skin irritation or rash develops.

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Aloe, Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 79097-020-28 1 Gallon Label1 Gallon Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN7
581662ethanol 0.7 ML/ML Topical GelSCD7
581662ethanol 70 % Topical GelSY7
581662ethyl alcohol 70 % Topical GelSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79097-020-012022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer
79097-020-022022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer
79097-020-032022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer
79097-020-042022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer
79097-020-082022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer
79097-020-122022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer
79097-020-162022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer
79097-020-282022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer
79097-020-752022-07-29C16284748780-1e4f33bdf-9dd6-d8a0-e053-dadaa90a6e4e27129 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79097-020-01AFFEX Care Ultra Hand Sanitizer50 mL in 1 BOTTLE, PLASTICGEL507
79097-020-02AFFEX Care Ultra Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL597
79097-020-03AFFEX Care Ultra Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1007
79097-020-04AFFEX Care Ultra Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1187
79097-020-08AFFEX Care Ultra Hand Sanitizer237 mL in 1 BOTTLE, PLASTICGEL2377
79097-020-12AFFEX Care Ultra Hand Sanitizer355 mL in 1 BOTTLE, PLASTICGEL3557
79097-020-16AFFEX Care Ultra Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4737
79097-020-28AFFEX Care Ultra Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37857
79097-020-75AFFEX Care Ultra Hand Sanitizer1000000 mL in 1 TANKGEL10000007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79097-020AFFEX CARE ULTRA HAND SANITIZER (ALCOHOL) GEL [AUTOTROL CORPORATION]7Legacy NDC, 9 package rows20211207_a14210e0-d09c-24b7-e053-2a95a90af67b.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79097-02079097-020-01, 79097-020-02, 79097-020-03, 79097-020-04, 79097-020-08, 79097-020-12, 79097-020-16, 79097-020-28, 79097-020-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
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
d27e4a65-c78b-1947-e053-2995a90ae51ca14210e0-d09c-24b7-e053-2a95a90af67b2021-12-06WarningsExact identifier
spl id: d27e4a65-c78b-1947-e053-2995a90ae51c
spl set id: a14210e0-d09c-24b7-e053-2a95a90af67b

Reported adverse events (FAERS/openFDA)#

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