Sani-Effect Gel Hand sanitizer Fresh Scent with Viatmin E and Aloe Vera

Manufacturer: Mann Lake Ltd
Effective date: 2022-08-29
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:50:33

Label at a glance#

ProductSDA 40B

Active ingredientALCOHOL

Label structure14 sections

Dosage and administration

Place enough product on the 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that can potentially 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.

Di 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 irriatation 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 the 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

glycerin, triethanolamine, carbomer, ethyl acetate, vitamin E, aloe vera, fragrance, purified water USP

8019-0116-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8019-0116-1

80194-116-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80194-0116-2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80194-0116-1	2024-01-30	C162847	48780-1	d6a99b39-4532-a426-e053-dadaa90af4c2	Sani-Effect Gel Hand sanitizer Fresh Scent with Viatmin E and Aloe Vera
80194-0116-2	2024-01-30	C162847	48780-1	d6a99b39-4532-a426-e053-dadaa90af4c2	Sani-Effect Gel Hand sanitizer Fresh Scent with Viatmin E and Aloe Vera
80194-0116-1	2022-08-29	C162847	48780-1	d6a99b39-4532-a426-e053-dadaa90af4c2	Sani-Effect Gel Hand sanitizer Fresh Scent with Viatmin E and Aloe Vera
80194-0116-2	2022-08-29	C162847	48780-1	d6a99b39-4532-a426-e053-dadaa90af4c2	Sani-Effect Gel Hand sanitizer Fresh Scent with Viatmin E and Aloe Vera
80194-0116-1	2022-01-28	C162847	48780-1	d6a99b39-4532-a426-e053-dadaa90af4c2	Sani-Effect Gel Hand sanitizer Fresh Scent with Viatmin E and Aloe Vera
80194-0116-2	2022-01-28	C162847	48780-1	d6a99b39-4532-a426-e053-dadaa90af4c2	Sani-Effect Gel Hand sanitizer Fresh Scent with Viatmin E and Aloe Vera

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80194-0116-1	SDA 40B	3.78 L in 1 PACKAGE	SOLUTION	3.78		2
80194-0116-2	SDA 40B	0.236 L in 1 PACKAGE	SOLUTION	0.236		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80194-0116	SDA 40B (ALCOHOL) SOLUTION [MANN LAKE LTD]	2	Legacy NDC, 2 package rows	20220831_63bbc638-6c86-463f-be41-1f65e15d7030.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

SDA 40B
Alcohol
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80194-0116	80194-0116-1, 80194-0116-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e76665b9-c382-010e-e053-2995a90ab151			63bbc638-6c86-463f-be41-1f65e15d7030	2022-08-29	Warnings	Exact identifier spl id: e76665b9-c382-010e-e053-2995a90ab151 spl set id: 63bbc638-6c86-463f-be41-1f65e15d7030

Reported adverse events (FAERS/openFDA)#

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