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.

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I.C.® Antibacterial Hand Cleaner

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

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) ℮

Principal Display Panel - 946 ml Bottle Label
I.C. ANTIBACTERIAL HAND CLEANER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Triethanolamine Lauryl Sulfate (UNII: E8458C1KAA)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59555-701-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2021
2NDC:59555-701-09473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2021
3NDC:59555-701-10946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2021
4NDC:59555-701-113780 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A07/01/2021
Labeler - R & R Lotion, Inc (062979000)

Revised: 9/2021
Document Id: cb004d42-6195-457c-9c1e-42d4fe9c5439
Set id: afd59808-4ab7-4752-b358-6b21b5d4ad30
Version: 1
Effective Time: 20210924
 
R & R Lotion, Inc