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NDC 56194-0501-01 Giant Eagle 130 mg/100mL Details

Giant Eagle 130 mg/100mL

Giant Eagle is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by GIANT EAGLE. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	56194-0501
Product ID	56194-501_e87442ff-9703-1519-e053-2a95a90a1e35
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	Giant Eagle
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	GIANT EAGLE
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 56194-0501-01 (56194050101)

Pricing Information	N/A
NDC Package Code	56194-501-01
Billing NDC	56194050101
Package	222 mL in 1 BOTTLE, PLASTIC (56194-501-01)
Marketing Start Date	2021-12-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d2cbdd6c-79c3-0726-e053-2a95a90a4651 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

Apply onto wet hands
Lather and rinse thoroughly.

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamide Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG – 120 Methyl Glucose Dioleate, PEG – 40 Hydrogenated Castor Oil, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 6 (CI 15985, Red 40 (CI 16035), Ext. Violet 2 (CI 60730).

Principal Display Panel

INGREDIENTS AND APPEARANCE

GIANT EAGLE

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56194-501
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
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56194-501-01	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/10/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/01/2021

Labeler - GIANT EAGLE (929989007)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(56194-501)

Revised: 9/2022

Document Id: e87442ff-9703-1519-e053-2a95a90a1e35

Set id: d2cbdd6c-79c3-0726-e053-2a95a90a4651

Version: 2

Effective Time: 20220912