Drug Labeling and Warnings

Drug Details [pdf]

OK FOAM ANTI-BACTERIAL- chloroxylenol soap 
Vectair Systems, 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

Chloroxylenol 0.75%

​Purpose

Skin Antimicrobial

​Use

Reduces amount of bacteria on hands.

​Warnings

For external use only.  Do not use in eyes.

Discontinue use if irritation & 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 & professional use only.

​Directions

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

​Inactive Ingredients

Water, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1

OK FOAM ANTI-BACTERIAL 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52007-600
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green (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: 52007-600-04	4 in 1 BOX	10/28/2016	06/30/2019
1		1000 mL in 1 BOTTLE, PUMP; 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	10/28/2016	06/30/2019

Labeler - Vectair Systems, Inc. (805347296)

Revised: 12/2018

Document Id: f500ba27-fade-4ba0-a6a1-bb8b4f4fd155

34390-5

Set id: 29f70fbb-c9db-447b-9e43-ce24bd9cc78e

Version: 2

Effective Time: 20181220