ALTAIR HAND CARE SYSTEM FOAM ANTI-BACTERIAL HAND- 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 six months of age.

For institutional & 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, Sodium Laurethy Sulfate, Propylene Glycol, Sodium Cumenesulfonate, Sodium Chloride, Chloroxylenol, DMDM Hydantoin, Fragrance, Yellow 5, Blue 1

Case Label x 3

ALTAIR HAND CARE SYSTEM FOAM ANTI-BACTERIAL HAND 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52007-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen (green (yellow-green) dispensed as white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52007-200-044 in 1 BOX05/05/201411/01/2017
11000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:52007-200-033 in 1 BOX05/05/201411/01/2017
21200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/28/201411/01/2017
Labeler - Vectair Systems, Inc. (805347296)

Revised: 12/2017
Document Id: 8c9c0be2-c7f3-458f-9da4-c7b5c35bf3d8
Set id: fce3ee0e-f805-4885-834b-b8d3fb112c32
Version: 2
Effective Time: 20171221
 
Vectair Systems, Inc.