Clear Bac by Wayne Concept Manufacturing Co Inc Wayne Clear Bac 2368

Clear Bac by

Drug Labeling and Warnings

Clear Bac by is a Otc medication manufactured, distributed, or labeled by Wayne Concept Manufacturing Co Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEAR BAC- benzalkonium liquid 
Wayne Concept Manufacturing 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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Wayne Clear Bac 2368

Active Ingredients

Benzalkonium Chloride (BZK) 0.13%

Purpose

Antiseptic

Uses:

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Wet hands with water.

Dispense enough Clear bac to work into a lather.

Continue washing for at least 30 seconds.

If hands are heavily soiled, a second application may be required.

Rinse hands with clean water and dry thoroughly.

Inactive Ingredients:

Water (aqua), alkyl polyglucoside, cocobetaine, lauramine oxide, glycerin, aloe barbadensis leaf juice, sodium EDTA, citric acid, fragrance, 5-Chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-2H-isothiazol-3-one.

Wayne

Improved Formula

Select Line

Clear Bac

Antibacterial Foam Hand Cleaner

Fights germs Leaves hands soft and clean

Reduces soap usage Nonstaining

Pleasant fragrance Contains aloe vera

Caution: Eye irritant. For external use only. See rear panel

for additional Cautions and First Aid.

KEEP OUT OF REACH OF CHILDREN

Manufactured by:

Wayne Concept Manufacturing Co., Inc.

Fort Wayne, IN 46825 260-482-8615

Serving the maintenance community since 1933

CLEAR BAC 
benzalkonium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64495-2368
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCO-BETAINE (UNII: 03DH2IZ3FY)
POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64495-2368-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/13/2020	12/15/2022

Labeler - Wayne Concept Manufacturing Co Inc (198433179)

Registrant - Wayne Concept Manufacturing Co Inc (198433179)

Establishment
Name	Address	ID/FEI	Business Operations
Wayne Concept Manufacturing Co Inc		198433179	manufacture(64495-2368)

Revised: 11/2022

Document Id: ed1fe249-5e11-320b-e053-2995a90ab060

34390-5

Set id: b40058b3-071a-db33-e053-2995a90a51dc

Version: 3

Effective Time: 20221110