Search by Drug Name or NDC

NDC 00363-7211-56 Walgreens 1.3 mg/mL Details

Walgreens 1.3 mg/mL

Walgreens is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREEN COMPANY. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	00363-7211
Product ID	0363-7211_e87ed76f-5ab1-9cc4-e053-2a95a90ada21
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	Walgreens
Proprietary Name Suffix	ANTIBACTERIAL HAND REFILL
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	WALGREEN COMPANY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00363-7211-56 (00363721156)

Pricing Information	N/A
NDC Package Code	0363-7211-56
Billing NDC	00363721156
Package	1650 mL in 1 BOTTLE, PLASTIC (0363-7211-56)
Marketing Start Date	2019-04-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 54f9feac-f302-4000-8a43-27cc4fdebb4f Details

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Helps eliminate bacteria on hands

Warnings

For external use only.

When using this product

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop use and ask doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

use to refill a hand soap pump bottle
from pump bottle, apply onto wet hands
lather and rinse thoroughly

Other informaton

store at room temperature

Inactive ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200)

Questions or comments?

1-800-925-4733

Label Copy

INGREDIENTS AND APPEARANCE

WALGREENS ANTIBACTERIAL HAND REFILL

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-7211
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-7211-56	1650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/22/2019

Labeler - WALGREEN COMPANY (008965063)

Registrant - APOLLO HEALTH AND BEAUTY CARE INC. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE INC.		201901209	manufacture(0363-7211)

Revised: 9/2022

Document Id: e87ed76f-5ab1-9cc4-e053-2a95a90ada21

Set id: 54f9feac-f302-4000-8a43-27cc4fdebb4f

Version: 3

Effective Time: 20220912