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RxNorm Names

CHLORHEXIDINE GLUCONATE solution
[Aurora Pharmaceutical LLC]


Category DEA Schedule Marketing Status
OTC ANIMAL DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

INDICATIONS

An antiseptic and antimicrobial disinfectant which provides fast-acting activity against a wide range of microorganisms, especially against those commonly found on the skin. A non-toxic, non-irritating agent possessing a wide range of antiseptic and antimicrobial activity against organisms which infect the skin, such as bacteria, fungi, ringworm and yeast.

WARNING

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

CAUTION

For external use only.

Avoid contact with eyes, ears and mucous membranes.

If contact occurs, immediately flush with water.

KEEP OUT OF REACH OF CHILDREN

DILUTION

Add 1 ounce (2 tablespoons) of Chlorhexidine Gluconate solution per gallon of clean water.

DIRECTIONS FOR USE

Rinse area to be disinfected with an ample amount of the Chlorhexidine Gluconate solution. Wipe away excess and pat dry with a sterile gauze or sponge.

Store at controlled room temperature between 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Do not freeze.

ACTIVE INGREDIENT

Chlorhexidine Gluconate     2% w/v

REORDER NO: 31007

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256

www.aurorapharmaceutical.com
IN 50-1129 03/2013

MANUFACTURED IN THE USA

Image

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

PRO-TEC™

Chlorhexidine Gluconate
2% w/v Solution

Antiseptic – Disinfectant

For External Animal Use Only

1 Gallon (3.79 L)

aurora
PHARMACEUTICAL

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label
CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate solution
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:51072-045
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorhexidine Gluconate (Chlorhexidine) Chlorhexidine Gluconate20 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
Water986 g  in 1 L
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51072-045-014 in 1 CARTON
13.79 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/02/2011
Labeler - Aurora Pharmaceutical LLC (832848639)
Establishment
NameAddressID/FEIBusiness Operations
Aurora Pharmaceutical LLC832848639MANUFACTURE

Revised: 9/2013
 
Aurora Pharmaceutical LLC

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