WHISKCARE 387- triclosan 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

Triclosan 0.30% 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 six months of age.
For institutional and professional use only.

Directions

Wet hands and forearms.
Apply a palmful to hands and forearms.
Scrub throughly for at least fifteen seconds.
Rinse completely and dry.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Propylene Glycol, Sodium Cumenesulfonate, Sodium Chloride, Chloroxylenol, DMDM Hydantoin, Fragrance, Yellow 5, Blue 1

LLabel - 1 gallon

WHISKCARE 387
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65585-387
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3.0 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CUMENESULFONATE (UNII: 5798KA13PG)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green (apple green, dispensed as a white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65585-387-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/14/2007	09/01/2017
2	NDC:65585-387-02	6 in 1 BOX	02/14/2007	09/01/2017
2		1750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC:65585-387-03	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/14/2007	09/01/2017
4	NDC:65585-387-04	4 in 1 BOX	02/14/2007	09/01/2017
4		4000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
5	NDC:65585-387-05	6 in 1 BOX	02/14/2007	09/01/2017
5		500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
6	NDC:65585-387-06	8 in 1 BOX	02/14/2007	09/01/2017
6		1000 mL in 1 BAG; Type 0: Not a Combination Product
7	NDC:65585-387-07	3 in 1 BOX	02/14/2007	09/01/2017
7		1200 mL in 1 BAG; Type 0: Not a Combination Product
8	NDC:65585-387-08	6 in 1 BOX	02/14/2007	09/01/2017
8		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/14/2007	09/01/2017

Labeler - Whisk Products, Inc. (834270639)

Name	Address	ID/FEI	Business Operations
Establishment
Whisk Products, Inc.		834270639	manufacture(65585-387)

Revised: 6/2017

Document Id: c83b047e-c565-4ab5-859e-7fdb72d3eb25

Set id: 51c6bcda-dba8-43b9-aa20-b5fbbc760388

Version: 4

Effective Time: 20170619

Whisk Products, Inc.

Active Ingredient

﻿Purpose

﻿Use

﻿Warnings

﻿Directions

﻿Inactive Ingredients

Purpose

Use

Warnings

Directions

Inactive Ingredients