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) ℮

Principal Display Panel -- 946 ml Bottle Label
(click image for full-size original)
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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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