Novo Foaming E2 Sanitizing Hand Soap Fragrance and Dye Free

Novo Foaming E2 Sanitizing Hand Fragrance and Dye Free by

Drug Labeling and Warnings

Novo Foaming E2 Sanitizing Hand Fragrance and Dye Free by is a Otc medication manufactured, distributed, or labeled by Noble Chemical, Envirochem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NOVO FOAMING E2 SANITIZING HAND FRAGRANCE AND DYE FREE- benzalkonium chloride liquid 
Noble Chemical

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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Novo Foaming E2 Sanitizing Hand Soap Fragrance and Dye Free

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13% w/v

Purpose

Antibacterial Agent

Uses

For handwashing to decrease bacteria on skin.

Warnings

For external use only. 

Do not use

in the eyes. If eye contact occurs, flush with water.

Stop use and ask a doctor if

redness and irritation occur and last for more than 72 hours.

Keep out of reach of children.

If swallowed, contact a physician or poison control center.

Directions

Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Inactive Ingredients

Water, Cocoamidopropyl Betaine, Propylene Glycol, Hexahydro-1,3,5-Tris(2-Hydroxyethyl)-S-Triazine

Package Labeling:

NOVO FOAMING E2 SANITIZING HAND FRAGRANCE AND DYE FREE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81551-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIS(N-HYDROXYETHYL) HEXAHYDROTRIAZINE (UNII: OU2JEB22IE)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81551-001-00	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/01/2021	07/01/2021

Labeler - Noble Chemical (170348663)

Establishment
Name	Address	ID/FEI	Business Operations
Envirochem, Inc.		078637253	manufacture(81551-001)

Revised: 4/2022

Document Id: dcefde77-613f-aa8b-e053-2995a90af1fe

34390-5

Set id: c3532b23-0166-a4b7-e053-2a95a90a8ab5

Version: 4

Effective Time: 20220418