56194-501, Citrus Fresh Antibacterial Liq Hand Soap

Giant Eagle by

Drug Labeling and Warnings

Giant Eagle by is a Otc medication manufactured, distributed, or labeled by GIANT EAGLE, Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GIANT EAGLE- benzalkonium chloride soap 
GIANT EAGLE

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

56194-501, Citrus Fresh Antibacterial Liq Hand Soap

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

GIANT EAGLE 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56194-501
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - GIANT EAGLE (929989007)

Registrant - Apollo Health and Beauty Care (201901209)

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

Revised: 9/2022

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

34390-5

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

Version: 2

Effective Time: 20220912