UNIVERSITY OF MICHIGAN- hand sanitizer gel

University of Michigan by

Drug Labeling and Warnings

University of Michigan by is a Otc medication manufactured, distributed, or labeled by Double Body Biotech Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol 75%

Purpose

Antiseptic

Use

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

Warnings

For external use Only.

• Flammable. Keep away from heat or flame.

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.

Do not use

• In children less than 2 months of age.
• On open skin wounds.

Directions

• Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 106 F(41℃)

Inactive ingredients

Water, Glycereth-26, Carbomer, Sodium Hydroxide, Aloe Barbadensis Leaf Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIVERSITY OF MICHIGAN 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74657-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERETH-26 (UNII: NNE56F2N14)
CARBOMER 980 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74657-016-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/08/2020

Labeler - Double Body Biotech Limited (560246954)

Registrant - Double Body Biotech Limited (560246954)

Establishment
Name	Address	ID/FEI	Business Operations
Double Body Biotech Limited		560246954	manufacture(74657-016)