BAYES ALCOHOL FREE HYDRATING HAND SANITIZER- benzalkonium chloride spray
LAB-CLEAN, 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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BAYES Hand Sanitizer

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

When using this product, avoid contact with eyes. In case of eye contact flush eyes with water.

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

Spray a small amount of product into palm of hand. Rub thoroughly over all surfaces of both hands.
Rub hands together briskly until dry

Inactive ingredients

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

Principal Display Panel

BAYES ALCOHOL FREE HYDRATING HAND SANITIZER
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73126-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73126-002-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/21/2020	04/20/2024
2	NDC:73126-002-02	88 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/21/2020	04/20/2024
3	NDC:73126-002-03	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/21/2020	04/20/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/21/2020	04/20/2024

Labeler - LAB-CLEAN, INC (199822219)

Name	Address	ID/FEI	Business Operations
Establishment
LAB-CLEAN, INC		199822219	manufacture(73126-002)

Revised: 4/2022

Document Id: dd937274-7fb4-2339-e053-2a95a90a74eb

Set id: 844059e7-c79d-449d-a93e-f09694189ed5

Version: 3

Effective Time: 20220426

LAB-CLEAN, INC