PREMIUM ANTIBACTERIAL HAND- benzalkonium chloride soap
Insolcorp, LLC

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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Premium Antibacterial Hand Soap

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

PURPOSE

Antibacterial

USE

For washing to decrease bacteria on the skin

WARNINGS

For external use only

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. Incase of eye contact flush with water.

STOP USE AND ASK A DOCTOR IF irritation and redness develops

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, get medical help or contact a poision control
center right away.

DIRECTIONS

Pump into dry hands and forearms, lather for atleast 15 seconds, rinse and dry.

INACTIVE INGREDIENTS

Water, Caprylyl / Capryl Glucosides, Laurtrimonium Chloride, Cocamidoprpylamine Oxide, Citric Acid, Fragrance

PRINCIPAL DISPLAY PANEL

PREMIUM ANTIBACTERIAL HAND SOAP

LEMON BLOSSOM

12 FL. OZ. (354 mL)

image description

PREMIUM ANTIBACTERIAL HAND
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74811-002
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74811-002-02	354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/08/2020

Labeler - Insolcorp, LLC (080539371)

Name	Address	ID/FEI	Business Operations
Establishment
Insolcorp, LLC		080539371	manufacture(74811-002)