OTC Medication Information: I.C. Antibacterial Hand Cleaner

I.C. ANTIBACTERIAL HAND CLEANER- benzalkonium chloride soap
R & R Lotion, Inc

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.

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin

Warnings

For external use only

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a poison Control Center right away.

Directions

• Pump into DRY hands.
• Lather vigorously for at least 15 seconds
• Rinse and dry throughly

Inactive Ingredients

Water, Triethanolamine Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide Monoethanolamine, Sodium Chloride, Gluconolactone (and) Sodium Benzoate, Citric Acid, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL — 946 ml Bottle Label

I.C.^®
Antibacterial
Hand
Cleaner

R&R LOTION
USA

Kills Germs

32oz. (946ml) ℮

I.C. ANTIBACTERIAL HAND CLEANER benzalkonium chloride soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-701 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (BENZALKONIUM) Benzalkonium Chloride 1.3 mg in 1 mL

Inactive Ingredients Ingredient Name Strength water Triethanolamine Lauryl Sulfate SODIUM LAURETH-3 SULFATE Cocamidopropyl Betaine COCO MONOETHANOLAMIDE SODIUM CHLORIDE GLUCONOLACTONE SODIUM BENZOATE CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59555-701-08 236 mL in 1 BOTTLE, PUMP None 2 NDC:59555-701-09 473 mL in 1 BOTTLE, DISPENSING None 3 NDC:59555-701-10 946 mL in 1 BOTTLE, PUMP None 4 NDC:59555-701-11 3780 mL in 1 BOTTLE, DISPENSING None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 07/01/2021

Labeler — R & R Lotion, Inc (062979000)

Revised: 09/2021 R & R Lotion, Inc