SANITEX MVP FOAM ANTI-BACTERIAL- triclosan 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

Triclosan 0.3% 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 & redness develop. If condition persists for more than 72 hours, consult a physician.

Not for use on children under 6 months of age.

For institutional & professional use only.

Directions

Inactive Ingredients

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

Case Label - 3 x 1200 mL

SANITEX MVP FOAM ANTI-BACTERIAL 
triclosan soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52007-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3.0 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 (yellow-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:52007-100-04 4 in 1 BOX
1 1000 mL in 1 BOTTLE, PUMP
2 NDC:52007-100-03 3 in 1 BOX
2 1200 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/24/2012
Labeler - Vectair Systems, Inc. (805347296)

Revised: 9/2012
Document Id: cffb27bf-e90b-4bcd-8652-c3ae1cc61e3c
Set id: 4b3b0890-4498-443b-96a4-bb1dcf1497f6
Version: 1
Effective Time: 20120924
 
Vectair Systems, Inc.