PRIME SOURCE E2 FOAM SO AP- chloroxylenol liquid
BUNZL

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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PRIME SOURC®E E2 Foam Soap

Active ingredient

Chloroxylenol 0.5%

Purpose

Antimicrobial

Use

Handwash to help decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands.
Apply product and thoroughly cover hands with lather.
Rinse well and dry hands completely.

Inactive ingredients

Water (Aqua), Alcohol, Lauric Acid, Ethanolamine, Dipropylene Glycol, Lactic Acid, Poloxamer 124, Isopropyl Alcohol, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Methylparaben, Propylparaben

Product Label

PRIME SOURCE E2 FOAM SO AP
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66294-523
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	Chloroxylenol	0.5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
LAURIC ACID (UNII: 1160N9NU9U)
MONOETHANOLAMINE (UNII: 5KV86114PT)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
POLOXAMER 124 (UNII: 1S66E28KXA)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM SULFITE (UNII: VTK01UQK3G)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66294-523-42	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2015
2	NDC:66294-523-67	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/15/2015

Labeler - BUNZL (799540588)