GAIN  ULTRA LEMON ZEST- triclosan soap 
Procter & Gamble Manufacturing Company

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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Gain Ultra Lemon Zest AB

DRUG FACTS

Active Ingredient

Triclosan 0.10%

Purpose

Antibacterial hand soap

Use

  • For handwashing to decrease bacteria on the skin

Warnings

For external use only

Keep out of reach of children.

In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

Directions

  • Wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

Inactive ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, lauramine oxide, sodium chloride, phenoxyethanol, PEI-14 PEG-10/PPG-7 copolymer, methylisothiazolinone, fragrance, yellow 5.

Questions?

1-800-616-2392

Distributed by PROCTER & GAMBLE, CINCINNATI, OH 45202.

PRINCIPAL DISPLAY PANEL - 887 mL Bottle Label

ULTRA
GAIN

dishwashing liquid

ANTIBACTERIAL
HAND SOAP

Lemon Zest

887 mL (1.87 PT) 30 FL OZ

FPO

99611552

Principal Display Panel - 887 mL Bottle Label
GAIN   ULTRA LEMON ZEST
triclosan soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-615
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (Triclosan) Triclosan0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURYL SULFATE 
SODIUM LAURETH SULFATE 
LAURAMINE OXIDE 
SODIUM CHLORIDE 
PHENOXYETHANOL 
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-615-11325 mL in 1 BOTTLE, PLASTIC
2NDC:37000-615-28828 mL in 1 BOTTLE, PLASTIC
3NDC:37000-615-30887 mL in 1 BOTTLE, PLASTIC
4NDC:37000-615-561660 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E02/01/2011
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIBusiness Operations
The Procter & Gamble Manufacturing Company007130032ANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK

Revised: 10/2011
 
Procter & Gamble Manufacturing Company