LEWCIZER 3- alcohol liquid 
A.P. Nonweiler Co., Inc.

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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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

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

Other information

Inactive ingredients

hydrogen peroxide, aloe vera gel, sterile water

Package Label - Principal Display Panel

500 mL NDC: 74829-359-08

500 mL

946.35 mL NDC: 74829-359-04

946.35 mL NDC: 74829-359-04

3785.41 mL NDC: 74829-359-01

Gallon

18927.06 mL NDC: 74829-359-05

Pail

208197.65 mL NDC: 74829-359-50

Drum

1040988.24 mL NDC: 74829-359-25

Tote

3785.41 mL NDC: 74829-359-01IS2

3785.41 mL NDC: 74829-359-01IS2

LEWCIZER 3 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74829-359
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74829-359-04946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
2NDC:74829-359-013785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
3NDC:74829-359-0518927.06 mL in 1 PAIL; Type 0: Not a Combination Product04/16/2020
4NDC:74829-359-50208197.65 mL in 1 DRUM; Type 0: Not a Combination Product04/22/2020
5NDC:74829-359-251040988.24 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/22/2020
6NDC:74829-359-08500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/16/2020
Labeler - A.P. Nonweiler Co., Inc. (006069298)
Establishment
NameAddressID/FEIBusiness Operations
A.P. Nonweiler Co., Inc.006069298manufacture(74829-359)

Revised: 10/2020
Document Id: b2bc3267-924b-2497-e053-2a95a90a26c8
Set id: a3e915c9-1b5c-c268-e053-2a95a90a857b
Version: 4
Effective Time: 20201028
 
A.P. Nonweiler Co., Inc.