Foaming Hand Cleaner by National Chemical Laboratories Of PA., Inc. / Kutol Products Company Afia F213F NCL

Foaming Hand Cleaner by

Drug Labeling and Warnings

Foaming Hand Cleaner by is a Otc medication manufactured, distributed, or labeled by National Chemical Laboratories Of PA., Inc., Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOAMING HAND CLEANER- foaming hand cleaner liquid 
National Chemical Laboratories Of PA., Inc.

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Afia F213F NCL

Active Ingredient - Benzalkonium Chloride 0.13% w/w.

Purpose - Antivacterial Agent

Uses - For handwashing to decrease bacteria on skin.

Warnings

For external use only.

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

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

Keep our of reach of children. If swallowed, contact physician or poison control center.

Directions

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

Inactive ingredients

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Lautrimonium Chloride, Iodopropynyl Butlcarbamate, Methylisothiazolinone.

FOAMING HAND CLEANER 
foaming hand cleaner liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71023-213
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
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BASIC YELLOW 5 (UNII: 07BP340B4T)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71023-213-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/18/2024

Labeler - National Chemical Laboratories Of PA., Inc. (002289619)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(71023-213)

Revised: 10/2024

Document Id: 23971cce-b83b-d1e5-e063-6394a90a6081

34390-5

Set id: 1b2b6579-7259-4e34-e063-6394a90afe08

Version: 3

Effective Time: 20241003

 

Nat