HEALTH GUARD ANTIBACTERIAL HAND CLEANSER F217F- benzalkonium chloride soap

Health Guard Antibacterial Hand cleanser by

Drug Labeling and Warnings

Health Guard Antibacterial Hand cleanser by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Ingrediente activo
Cloruro de benzalconio

PURPOSE

Purpose

Antibacterial agent

Propósito
Agente antibacteriano

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, a physician or contact a poison control center right away.

Manténgase fuera del alcance de los niños. Si se ingiere, consulte a un médico o contacte inmediatamente con un centro de control de envenenamiento.

INDICATIONS & USAGE

Uses For handwashing to decrease bacteria on the skin.

Usos Para lavar las manos para disminuir las bacterias en la piel.

DOSAGE & ADMINISTRATION

Directions

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

Direcciones
Aplique una pequeña cantidad, cubriendo las manos con el producto durante 30 segundos. Añada agua, espolvoree y enjuague

INACTIVE INGREDIENT

Inactive Ingredients

water, cetrimonium chloride, lauramine oxide, sorbitol, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, sodium lauraminodipropionate, citric acid, fragrance, disodium EDTA, methyisothiazolinone, methylchloroisothiazolinone, blue 1.

Ingredientes inactivos
agua, cloruro de cetrimonio, óxido de lauramina, sorbitol, cocamida MEA, cloruro de sodio, PEG-120 metil diolato de glucosa, lauraminodipropionato de sodio, ácido cítrico, fragancia, EDTA disódico, metiisotiazolinona, metilcloroisotiazolinona, azul 1.

WARNINGS

Warnings
For external use only.
Avoid contact with eyes. If contact occurs, flush with water.
Stop use and ask a doctor if in rare instances, redness and irritation develops and persists.

Advertencias
Sólo para uso externo.
Evitar el contacto con los ojos.
Deje de usar y consulte a un médico si en raras ocasiones se desarrolla y persiste enrojecimiento e irritación.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTH GUARD ANTIBACTERIAL HAND CLEANSER  F217F
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-217
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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SORBITOL (UNII: 506T60A25R)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-217-65	800 mL in 1 BAG; Type 0: Not a Combination Product	09/29/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/29/2017

Labeler - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(50865-217)