WHISKCARE 377- 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.

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Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

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

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

Bottle Label - 1 Gallon Short Neck

WHISKCARE 377 
benzalkonium chloride soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65585-577
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.00 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color white (water white - colorless, dispensed as a white foam) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65585-577-01 50 mL in 1 BOTTLE, PUMP
2 NDC:65585-577-02 6 in 1 BOX
2 1750 mL in 1 BOTTLE, PUMP
3 NDC:65585-577-03 6 in 1 BOX
3 500 mL in 1 BOTTLE, PUMP
4 NDC:65585-577-04 3785 mL in 1 BOTTLE, PLASTIC
5 NDC:65585-577-05 4 in 1 BOX
5 4000 mL in 1 BOTTLE, PUMP
6 NDC:65585-577-06 8 in 1 BOX
6 1000 mL in 1 BAG
7 NDC:65585-577-07 208198 mL in 1 DRUM
8 NDC:65585-577-08 3 in 1 BOX
8 1200 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/12/2005
Labeler - Whisk Products, Inc. (834270639)
Establishment
Name Address ID/FEI Business Operations
Whisk Products, Inc. 834270639 manufacture(65585-577)

Revised: 10/2012
Document Id: e8d0b80f-e524-43c1-b368-fb81b5722829
Set id: 3a63b1f6-8187-46b5-8767-cbb836fd4a51
Version: 4
Effective Time: 20121010
 
Whisk Products, Inc.