HAPPY HANDS HAND SANITIZER- alcohol liquid

Happy Hands Hand Sanitizer by

Drug Labeling and Warnings

Happy Hands Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by South Tenth Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Ethyl Alcohol 80%

Purpose

Antiseptic

Use[s]

Health care personnel hand rub to help reduce bacteria that potentially can cause disease. 

Warnings

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

Do not use

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

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use & 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.

Directions

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

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

Inactive Ingredients

Distilled water, glycerol, hydrogen peroxide, denatonium benzoate.

Package Labeling: 100ml

Package Labeling: 300mL

Package Labeling: 500 mL

INGREDIENTS AND APPEARANCE

HAPPY HANDS HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78705-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78705-001-00	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 78705-001-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 78705-001-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - South Tenth Development, LLC (117521920)