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NDC 00363-0589-01 First Aid Antiseptic Wipes 0.0013 mg/100mg Details

First Aid Antiseptic Wipes 0.0013 mg/100mg

First Aid Antiseptic Wipes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen CO. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	00363-0589
Product ID	0363-0589_e6c2450a-9e08-4b2d-b04e-35a7905e3725
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	First Aid Antiseptic Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride (0.13%)
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.0013
Active Ingredient Units	mg/100mg
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Walgreen CO
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 00363-0589-01 (00363058901)

Pricing Information	N/A
NDC Package Code	0363-0589-01
Billing NDC	00363058901
Package	20 PACKET in 1 CARTON (0363-0589-01) / 1 mg in 1 PACKET
Marketing Start Date	2017-02-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3d88dcc6-9cc7-46f5-9928-c019a035ee70 Details

Active ingredients

Benalkonium chloride (0.13%)

Purpose

First Aid Antiseptic

Use

first aid to help prevent the rist of infection in minor cuts, scrapes, and burns

Warnings

For external use only

Do Not Use

in the eyes or apply over large areas of the body.

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and ask a doctor if

the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Keep out of reach of children.

If swallowed, get medical help or contqact a Poison Control Center right away

Directions:

clean the affected area
apply a small amount of this product on the area 1 to 3 times daily
may be covered with a sterile bandage
if bandaged, let dry first

Inactive ingredients

water, glycerin, sodium cocoamphoacetate, Aloe barbadensis leaf juice, tocopheryl acetate, fragrance, polysorbate 20, tetrasodium EDTA, phenoxyethanol, methylparaben, ethylparaben, potassium sorbate, sodium benzoate, sodium hydroxide, citric acid

adverse reactions

Walgreens Pharmacist Survey Study, November 2014

Questions or comments? 1-800-925-4733

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com 2016 Walgreen Co.

MADE IN ISRAEL

principal display panel

NEW

Well at

Walgreens

WALGREENS PHARAMACIST RECOMMENDED

FIRST AID

Antiseptic

Wipes

Benzalkonium chloride

Antiseptic Cleansing Agent
Helps reduce the risk of infection in minor cuts, scrapes and burns

20 WIPES

5.5 IN X 7.8 IN (140 mm x 200 mm)

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC WIPES

benzalkonium chloride (0.13%) cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0589
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.0013 mg in 100 mg

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE SODIUM (UNII: MP1J8420LU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0589-01	20 in 1 CARTON	02/08/2017
1		1 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/08/2017

Labeler - Walgreen CO (008965063)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Albaad		143406457	manufacture(0363-0589)

Revised: 3/2022

Document Id: e6c2450a-9e08-4b2d-b04e-35a7905e3725

Set id: 3d88dcc6-9cc7-46f5-9928-c019a035ee70

Version: 10

Effective Time: 20220322