OTC Medication Information: Giant Eagle

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.

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 a Poison Control Center immediately.

Directions

• Apply onto wet hands
• Lather and rinse thoroughly.

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ext. Violet 2 (CI 60730).

Principal Display Panel

GIANT EAGLE benzalkonium chloride soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56194-502 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 130 mg in 100 mL

Inactive Ingredients Ingredient Name Strength METHYLCHLOROISOTHIAZOLINONE WATER LAURAMIDOPROPYLAMINE OXIDE GLYCERIN CETRIMONIUM CHLORIDE SODIUM CHLORIDE METHYLISOTHIAZOLINONE COCO MONOETHANOLAMIDE PEG-120 METHYL GLUCOSE DIOLEATE FRAGRANCE CLEAN ORC0600327 CITRIC ACID MONOHYDRATE EDETATE SODIUM SODIUM SULFATE FD&C YELLOW NO. 5 FD&C RED NO. 40 D&C RED NO. 33

Product Characteristics Color Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:56194-502-01 222 mL in 1 BOTTLE, PLASTIC None

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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	Operations
Apollo Health and Beauty Care		201901209	manufacture (56194-502)

Revised: 09/2022 GIANT EAGLE