LEWCIZER 6- alcohol liquid

Lewcizer 6 by

Drug Labeling and Warnings

Lewcizer 6 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

fragrance, glycerin, hydrogen peroxide, sterile water

Package Label - Principal Display Panel

250 mL NDC: 74829-365-08

500 mL NDC: 74829-365-16

3785 mL NDC: 74829-365-01

18927 mL NDC: 74829-365-05

208197 mL NDC: 74829-365-50

1040988 mL NDC: 74829-365-25

INGREDIENTS AND APPEARANCE

LEWCIZER 6 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74829-365
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	81.1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.5 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	13 mL  in 100 mL
CITRAL (UNII: T7EU0O9VPP)	0.1 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	4.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74829-365-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2020
2	NDC: 74829-365-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2020
3	NDC: 74829-365-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2020
4	NDC: 74829-365-05	18927 mL in 1 PAIL; Type 0: Not a Combination Product	07/23/2020
5	NDC: 74829-365-50	208197 mL in 1 DRUM; Type 0: Not a Combination Product	07/23/2020
6	NDC: 74829-365-25	1040988 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	07/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/22/2020

Labeler - A.P. Nonweiler Co., Inc. (006069298)

Establishment
Name	Address	ID/FEI	Business Operations
A.P. Nonweiler Co., Inc.		006069298	manufacture(74829-365)