FOAMING ANTIBACTERIAL WASH by KUTOL PRODUCTS

FOAMING ANTIBACTERIAL WASH by

Drug Labeling and Warnings

FOAMING ANTIBACTERIAL WASH by is a Otc medication manufactured, distributed, or labeled by KUTOL PRODUCTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOAMING ANTIBACTERIAL WASH- benzalkonium chloride soap 
KUTOL PRODUCTS

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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BENZALKONIUM CHLORIDE ........0.13% w/w

PURPOSE ....Antibacterial agent

USES

For handwashing to decrease bacteria on skin

Directions

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

WARNINGS

For external use only.

Avoid contact with eyes. If contact occurs flush eyes with water.

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

KEEP OUT OF REACH OF CHILDREN

If swallowed, contact a physician or poison control center

INACTIVE INGREDIENTS

Water, lauramine oxide, PEG-7 glyceryl cocoate, glycerin, laurtrimonium chloride, cocamido PG-dimonium chloride phosphate polyquaternium-7, fragrance, wheat amino acids, aloe barbadensis leaf juice, tocopheryl acetate, methyisothiazolinone, methylchloroisothiazolinone, red 33.

FOAMING ANTIBACTERIAL WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-645
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-645-17	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/13/2017
2	NDC: 50865-645-31	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/13/2017	10/03/2017

Labeler - KUTOL PRODUCTS (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
KUTOL PRODUCTS		004236139	manufacture(50865-645)

Revised: 11/2019

Document Id: 9768edb2-dad0-6c8f-e053-2995a90a0f94

34390-5

Set id: 59149427-ce58-5a87-e053-2a91aa0a7399

Version: 4

Effective Time: 20191115