SDA 40B- alcohol solution

SDA 40B by

Drug Labeling and Warnings

SDA 40B by is a Otc medication manufactured, distributed, or labeled by Mann Lake Ltd, Mann Lake LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer.

Active Ingredient(s)

Alcohol 70% v/v. Purpose Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

For external use only.  Flammable.  Keep away from heat or flame.

Di not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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.

STOP USE

Stop use and ask a doctor if irriatation or rash occurs.  These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control center right away.

Directions

• 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

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

Inactive Ingredients

glycerin, triethanolamine, carbomer, purified water USP

80194-0101-1

Sanieffect Label Gel

80194-0101-2

INGREDIENTS AND APPEARANCE

SDA 40B 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80194-0101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	30 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80194-0101-1	3.78 L in 1 PACKAGE; Type 0: Not a Combination Product	05/13/2020
2	NDC: 80194-0101-2	0.236 L in 1 PACKAGE; Type 0: Not a Combination Product	05/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/13/2020

Labeler - Mann Lake Ltd (121181846)

Registrant - Mann Lake LTD (121181846)

Establishment
Name	Address	ID/FEI	Business Operations
Mann Lake Ltd		121181846	manufacture(80194-0101)