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NDC 00363-0242-04 Walgreen 130 mg/100mL Details

Walgreen 130 mg/100mL

Walgreen is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Co. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	00363-0242
Product ID	0363-0242_edc20f71-0290-1f15-e053-2a95a90a13a6
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	Walgreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	130
Active Ingredient Units	mg/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Walgreen Co
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0242-04 (00363024204)

Pricing Information	N/A
NDC Package Code	0363-0242-04
Billing NDC	00363024204
Package	1660 mL in 1 BOTTLE, PLASTIC (0363-0242-04)
Marketing Start Date	2021-08-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c992cf19-786c-d794-e053-2995a90af067 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 a doctor if

irritation or redness develops and lasts

Keep out of reach of children.

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

Directions

use to refill soap pump bottle
from pump bottle, apply onto wet hands
Lather and rinse thoroughly.

Other Information

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 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Questions or comments?

1-800-925-4733

Principal Display Panel

INGREDIENTS AND APPEARANCE

WALGREEN

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0242
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	130 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0242-04	1660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/06/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/06/2021

Labeler - Walgreen Co (008965063)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(0363-0242)

Revised: 11/2022

Document Id: edc20f71-0290-1f15-e053-2a95a90a13a6

Set id: c992cf19-786c-d794-e053-2995a90af067

Version: 2

Effective Time: 20221118