FDA.reportPublic FDA data

Simply Pure Hand Sanitizer

Manufacturer
KKJ & Associates LLC
Effective date
2020-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:09

Label at a glance#

ProductSimply Pure 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 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

This product is intended to help reduce bacteria on skin.

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

Aloe Barbadensis Leaf Juice, Carbomer, Glycerin, Lavendula Latifolia, Tocopherol Acetate, Triethanolamine, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79642-001-012022-01-28C16284748780-1d6a99b39-deec-a426-e053-dadaa90af4c2Simply Pure Hand Sanitizer
79642-001-022022-01-28C16284748780-1d6a99b39-deec-a426-e053-dadaa90af4c2Simply Pure Hand Sanitizer
79642-001-032022-01-28C16284748780-1d6a99b39-deec-a426-e053-dadaa90af4c2Simply Pure Hand Sanitizer
79642-001-042022-01-28C16284748780-1d6a99b39-deec-a426-e053-dadaa90af4c2Simply Pure Hand Sanitizer
79642-001-052022-01-28C16284748780-1d6a99b39-deec-a426-e053-dadaa90af4c2Simply Pure Hand Sanitizer
79642-001-062022-01-28C16284748780-1d6a99b39-deec-a426-e053-dadaa90af4c2Simply Pure Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79642-001-01Simply Pure Hand Sanitizer118 mL in 1 BOTTLEGEL1181
79642-001-02Simply Pure Hand Sanitizer296 mL in 1 BOTTLE, PUMPGEL2961
79642-001-03Simply Pure Hand Sanitizer355 mL in 1 BOTTLE, PUMPGEL3551
79642-001-04Simply Pure Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731
79642-001-05Simply Pure Hand Sanitizer946 mL in 1 BOTTLE, PUMPGEL9461
79642-001-06Simply Pure Hand Sanitizer3785 mL in 1 BOTTLE, PUMPGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79642-001SIMPLY PURE HAND SANITIZER (ALCOHOL) GEL [KKJ & ASSOCIATES LLC]1Legacy NDC, 6 package rows20200722_aa54f3ba-26ec-1644-e053-2995a90a3879.zip

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
79642-00179642-001-01, 79642-001-02, 79642-001-03, 79642-001-04, 79642-001-05, 79642-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
LAVENDER OILZBP1YXW0H8IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT

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
aa5443ce-23ff-1fa4-e053-2995a90a9887aa54f3ba-26ec-1644-e053-2995a90a38792020-07-13WarningsExact identifier
spl id: aa5443ce-23ff-1fa4-e053-2995a90a9887
spl set id: aa54f3ba-26ec-1644-e053-2995a90a3879

Reported adverse events (FAERS/openFDA)#

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