Active Ingredient(s)

Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

Do not use

in 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 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 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.

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

PEG-40 hydrogenated castor oil, Fragrance (Parfum), Tocopheryl acetate, Aloe barbadensis leaf extract, Phenoxyethanol, Ethylhexylglycerin, purified water USP

Package Label - Principal Display Panel

60 mL NDC: 51706-814-01 Snoozy olive

60 mL NDC: 51706-814-02 snoozy green

60 mL NDC: 51706-814-03

Snoozy blue

60 mL NDC: 51706-814-04

Snoozy pink

green 60 mL NDC: 51706-815-01

60 mL NDC: 51706-815-02 pink 60 mL NDC: 51706-815-03 blue

60 mL NDC: 51706-815-04 olive

60ml NDC 51706-816

HAND SANITIZER-SPRAY
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-814
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.0003 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-814-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:51706-814-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:51706-814-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:51706-814-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/30/2020

HAND SANITIZER-SPRAY
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-816
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.0003 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-816-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:51706-816-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:51706-816-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:51706-816-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/30/2020

HAND SANITIZER-SPRAY
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-815
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.0003 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-815-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:51706-815-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:51706-815-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:51706-815-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/30/2020

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Snoozy Freshners, LLC		075299630	label(51706-814)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51706-814, 51706-815, 51706-816)

Name	Address	ID/FEI	Business Operations
Establishment
DM imports, Ltd		799543041	label(51706-815)