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NDC 64709-0100-20 Benzalkonium Chloride 0.13 mg/mL Details

Benzalkonium Chloride 0.13 mg/mL

Benzalkonium Chloride is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Diamond Wipes International. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	64709-0100
Product ID	64709-100_643dfe7e-dea5-46b1-b0c5-4c7ab089d30a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Benzalkonium Chloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Antibacterial Wet Wipes
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Diamond Wipes International
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 64709-0100-20 (64709010020)

Pricing Information	N/A
NDC Package Code	64709-100-20
Billing NDC	64709010020
Package	75 mL in 1 POUCH (64709-100-20)
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9296f7ad-eab9-4336-b0fa-8297a070fd18 Details

Purpose

Antimicrobial

Active Ingredient

Benzalkonium Chloride 0.13%

Uses

For hand sanitizing to decrease bacteria on the skin
Safe for repeated use

Directions

Peel back label
remove and unfolod wipe
wipe hands thoroughly for approximately 30 seconds
dispose of used wipe in trash, do not flush

Warnings

For external use only

When using this product avoid contact with eyes, if in eyes rinse thoroughly with water

Discontinue use and ask a doctor if irritation and redness develops and conditions persist for more than 72 hours.

Keep Out Of Reach Of Children

If swollowed, get medical help or contact the Poison Control Center right away.

Aloe barbadensis leaf juice, citric acid, fragrance, glycerin, hamamelis virginiana (witch hazel) bark/leaf/twig/extract, phenoxyethanol, polysorbate 20, tocopheryl acetate, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE

antibacterial wet wipes swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64709-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
WITCH HAZEL (UNII: 101I4J0U34)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
polysorbate 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64709-100-20	75 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2016

Labeler - Diamond Wipes International (161104729)

Name	Address	ID/FEI	Business Operations
Establishment
Diamond Wipes International		161104729	manufacture(64709-100)

Revised: 4/2018

Document Id: 643dfe7e-dea5-46b1-b0c5-4c7ab089d30a

Set id: 9296f7ad-eab9-4336-b0fa-8297a070fd18

Version: 1

Effective Time: 20180404