AUTOSPRITZ- alcohol solution
ORIGYN LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS

Alcohol 80% v/v

INACTIVE INGREDIENTS

Glycerin, hydrogen peroxide, purified water USP

PURPOSE

Antiseptic

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.

INDICATIONS & USAGE

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.
Do not use
- for children less than 2 months of age
- on open skin wounds
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 of rash occurs. These may be signs of a serious health condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & 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.

Refill Bottle 33.8 fl oz (1L)

Auto Dispenser Bottle 12 fl oz (355ml)

AUTOSPRITZ
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79281-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 L in 100 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 L in 100 L
WATER (UNII: 059QF0KO0R)	18.425 L in 100 L

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79281-010-01	1 L in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2020
2	NDC:79281-010-02	0.355 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/02/2020

Labeler - ORIGYN LLC (117542954)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Shiruoni Cosmetics Co. Ltd		551125378	manufacture(79281-010)