Sanitelle Moisturizing Hand Sanitizer with Aloe

Manufacturer
BENTUS LABORATORII, OOO
Effective date
2021-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:34

Label at a glance#

ProductSanitelle Moisturizing Hand Sanitizer with Aloe
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 80% 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

Water, Propylene Glycol, Glycerin, , Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopherol, Aloe Barbadensis (Aloe Vera) Leaf Gel, CI 42090, CI 19140, Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 80068-006-50NDC: 80068-006-5050 mL NDC: 80068-006-50

NDC: 80068-006-25NDC: 80068-006-25250 mL NDC: 80068-006-25

Distibuted by: Flex Technologies, Inc, 10432 Balls Ford Rd. Suite 300, Manassas, VA 20109, USA

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80068-006-252023-01-30C16284748780-1f386c649-a3c6-0266-e053-dadaa90a7c1abc27a01c-73e1-4cd8-e053-2995a90abcbe
80068-006-502023-01-30C16284748780-1f386c649-a3c6-0266-e053-dadaa90a7c1abc27a01c-73e1-4cd8-e053-2995a90abcbe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80068-006-25Sanitelle Moisturizing Hand Sanitizer with Aloe250 mL in 1 BOTTLE, PUMPGEL2501
80068-006-50Sanitelle Moisturizing Hand Sanitizer with Aloe50 mL in 1 BOTTLEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80068-006SANITELLE MOISTURIZING HAND SANITIZER WITH ALOE (ALCOHOL) GEL [BENTUS LABORATORII, OOO]1Legacy NDC, 2 package rows20210226_bc27a01c-73e1-4cd8-e053-2995a90abcbe.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80068-00680068-006-50, 80068-006-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
bc279156-28df-edc1-e053-2a95a90a3aadbc27a01c-73e1-4cd8-e053-2995a90abcbe2021-02-25WarningsExact identifier
spl id: bc279156-28df-edc1-e053-2a95a90a3aad
spl set id: bc27a01c-73e1-4cd8-e053-2995a90abcbe

Reported adverse events (FAERS/openFDA)#

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