WHISKCARE 362- chloroxylenol soap

WhiskCare 362 by

Drug Labeling and Warnings

WhiskCare 362 by is a Otc medication manufactured, distributed, or labeled by Whisk Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active Ingredient

Chloroxylenol 0.75% w/w

​Purpose

Skin Antimicrobial

​Use

reduces amount of bacteria on hands

​Warnings

For external use only.  Do not use in eyes.

Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.

Not for use on children under 6 months of age.

For institutional and professional use only.

​Directions

• Wet hands and forearms.
• Apply a small amout (5 mL) or palmful to hands and forearms.
• Scrub thoroughly for at least fifteen seconds.
• Rinse completely and dry.

​Inactive Ingredients

​Water, Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Tetrasodium EDTA, Fragrance, Polyquaternium-7, Sodium Chloride, DMDM Hydantoin, Blue 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHISKCARE 362 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65585-562
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE SODIUM (UNII: MP1J8420LU)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (aqua blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65585-562-01	59 mL in 1 TUBE; Type 0: Not a Combination Product	01/23/2006
2	NDC: 65585-562-02	12 in 1 BOX	01/23/2006	01/03/2017
2		354.9 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 65585-562-03	12 in 1 BOX	01/23/2006
3		800 mL in 1 BAG; Type 0: Not a Combination Product
4	NDC: 65585-562-04	6 in 1 BOX	01/23/2006
4		1750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
5	NDC: 65585-562-05	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/23/2006
6	NDC: 65585-562-06	208198 mL in 1 DRUM; Type 0: Not a Combination Product	01/23/2006
7	NDC: 65585-562-07	10 in 1 BOX	01/23/2006
7		1200 mL in 1 BAG; Type 0: Not a Combination Product
8	NDC: 65585-562-08	4 in 1 BOX	01/23/2006
8		4000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
9	NDC: 65585-562-09	18 in 1 BOX	01/23/2006	01/03/2017
9		500 mL in 1 BAG; Type 0: Not a Combination Product
10	NDC: 65585-562-10	12 in 1 BOX	10/03/2006
10		236.59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
11	NDC: 65585-562-11	8 in 1 BOX	06/16/2006
11		1000 mL in 1 BAG; Type 0: Not a Combination Product
12	NDC: 65585-562-12	12 in 1 BOX	01/23/2006
12		800 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/23/2006

Labeler - Whisk Products, Inc. (834270639)

Establishment
Name	Address	ID/FEI	Business Operations
Whisk Products, Inc.		834270639	manufacture(65585-562)