LEWCIZER 3- alcohol liquid

Lewcizer 3 by

Drug Labeling and Warnings

Lewcizer 3 by is a Otc medication manufactured, distributed, or labeled by A.P. Nonweiler Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

Active Ingredient(s)

Alcohol 80% 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

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 irritation 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 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

hydrogen peroxide, aloe vera gel, sterile water

Package Label - Principal Display Panel

946.35 mL NDC: 74829-359-04

3785.41 mL NDC: 74829-359-01

18927.06 mL NDC: 74829-359-05

208197.65 mL NDC: 74829-359-50

1040988.24 mL NDC: 74829-359-25

INGREDIENTS AND APPEARANCE

LEWCIZER 3 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74829-359
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)	4.2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1.8 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74829-359-04	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020
2	NDC: 74829-359-01	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
3	NDC: 74829-359-05	18927.06 mL in 1 PAIL; Type 0: Not a Combination Product	04/16/2020
4	NDC: 74829-359-50	208197.65 mL in 1 DRUM; Type 0: Not a Combination Product	04/22/2020
5	NDC: 74829-359-25	1040988.24 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	04/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/16/2020

Labeler - A.P. Nonweiler (006069298)

Establishment
Name	Address	ID/FEI	Business Operations
A.P. Nonweiler		006069298	manufacture(74829-359)