KLEENFOAM- otc antimicrobial drug product aerosol, foam

KLEENFOAM by

Drug Labeling and Warnings

KLEENFOAM by is a Otc medication manufactured, distributed, or labeled by Dermarite Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Chloroxylenol 0.5%

Purpose:

Antiseptic Handwash

Uses:

• For handwashing to decrease bacteria on the skin.
• after changing diapers;
• after assisting ill persons;
• before contact with a person under medical care or treatmentRecommended for repeated use.

Warnings:

• For external use only.
• Avoid contact with eyes. In case of contact, flush thoroughly with water.
• Ask a doctor before use if you have , deep of puncture wounds, animal bites, serious burns
• When using this product, do not apply to areas of raw or blistered skin in large quantities, do not use in or near the eyes
• Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days or clear up and recur within a few days

Warnings:

For external use only.

Avoid contact with eyes. In case of contact, flush thoroughly with water.

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

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away

Directions:

• Wet hands and forearms.
• Apply 5 millimeters (teaspoon) or palmful to hands and forearms.
• Scrub thoroughly for 15 seconds.
• Rinse and repeat.

Other information:

Store at room temperature (59°-86°F). You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

Water, Sodium Lauryl sulfate, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Polysorbate 20, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Disodium EDTA, Sodium Isostearoyl lactylate, Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Citric Acid, Sodium Hydroxide

Question?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Kleenfoam Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

KLEENFOAM 
otc antimicrobial drug product aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-093
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.005 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEMON OIL (UNII: I9GRO824LL)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-093-34	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	12/12/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/12/2011

Labeler - Dermarite Industries LLC (883925562)

Registrant - Dermarite Industries LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
Dermarite Industries LLC		883925562	manufacture(61924-093)