C-000001228-064: Package Insert and Label Information

C-000001228-064- benzalkonium chloride soap
Whisk Products, 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.

​Active Ingredient

Benzalkonium Chloride 0.1%

​Purpose

Antimicrobial

​Uses

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

​Warnings

​For external use only ​.

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

​Stop use and ask a doctor if ​ irritation or redness develops, or if condition persists for more than 72 hours.

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

​Directions

  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.

​Inactive Ingredients

Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

Label for 55 gallon Drum
(click image for full-size original)

C-000001228-064
benzalkonium chloride soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65585-484
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.0 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE
GLYCERETH-2 COCOATE
BEHENTRIMONIUM CHLORIDE
DIHYDROXYETHYL COCAMINE OXIDE
Product Characteristics
Color white (water white — colorless, dispensed as a white foam) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65585-484-01 208198 mL in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/25/2006 12/18/2017
Labeler — Whisk Products, Inc. (834270639)
Establishment
Name Address ID/FEI Operations
Whisk Products, Inc. 834270639 manufacture (65585-484)

Revised: 12/2017 Whisk Products, Inc.

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