FOAM SAFE- povidone iodine liquid

Foam Safe by

Drug Labeling and Warnings

Foam Safe by is a Otc medication manufactured, distributed, or labeled by Gremed Manufacturing LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                   Purposes

Povidone Iodine 7.5% w/w .............. Antiseptic

PURPOSE

Uses

Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.

WARNINGS

Warnings

For External Use Only

Stope use and ask doctor if irritation or redness develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply a palmful (5g) of foam to hands and forearms. Scrub thoroughly for 2 minutes with a sterile scrub brush, paying particular attention to the nails, cuticles and interdigital spaces. Rinse and repeat scrub.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Lauramide DEA, Ammonium Lauryl Sulfate, PEG-7, Glyceryl Cocoate, Panthenol, Sodium Hydroxide, Potassium Iodate

PRINCIPAL DISPLAY PANEL

INDICATIONS & USAGE

If swallowed, get medical help or contact a poison control center right away. Avoid contact with eyes; in case of contact, flush eyes with water.

INGREDIENTS AND APPEARANCE

FOAM SAFE 
povidone iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47066-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)	POVIDONE-IODINE	7.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
POLYETHYLENE GLYCOL 350 (UNII: ZBR3T82M2V)
GLYCERYL COCOATE (UNII: WVK1CT5994)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM IODATE (UNII: I139E44NHL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47066-402-01	59 mL in 1 BOTTLE
2	NDC: 47066-402-02	118 mL in 1 BOTTLE
3	NDC: 47066-402-03	473 mL in 1 BOTTLE
4	NDC: 47066-402-04	500 mL in 1 BOTTLE
5	NDC: 47066-402-05	1000 mL in 1 BOTTLE
6	NDC: 47066-402-06	3785 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/01/2012

Labeler - Gremed Manufacturing LLC (832854041)