Foaming Hand Sanitizer by National Chemical Laboratories Of PA., Inc. / Kutol Products Company AFIA F207F NCL

Foaming Hand Sanitizer by

Drug Labeling and Warnings

Foaming Hand Sanitizer 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 SANITIZER- foaming hand sanitizer liquid 
National Chemical Laboratories Of PA., Inc.

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AFIA F207F NCL

Active Ingredient - Benzalkonium Chloride 0.13% w/w.

Purpose - Antibacterial Agent

Uses - Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

For external use only.

Avoid contact with eyes. If contact occurs, flush wyes 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 phsician or poison control.

Directions

Apply a small amount to palm. Briskly rub, covering hands with product until dry.

Inactive ingredients

Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), PEG-7 Glyceryl Cocoate, Fragrance/Parfum, Phenoxyethanol, Tetrasodium EDTA.

FOAMING HAND SANITIZER 
foaming hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71023-207
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FRAGRANCE LINEN ORC1900779 (UNII: 658A7B6MY1)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71023-207-41	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(71023-207)

Revised: 10/2024

Document Id: 23975e36-b3ab-1b81-e063-6394a90ab7e3

34390-5

Set id: 1b2c1126-c44b-2cb3-e063-6394a90a4b7f

Version: 2

Effective Time: 20241003

 

Nat