ANTIBACTERIAL ANTIFUNGAL MEDICATED- chlorhexidine gluconate, ketoconazole shampoo 
Alpha Paw Inc

Disclaimer: 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.

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ANTIBACTERIAL & ANTIFUNGAL MEDICATED SHAMPOO

ACTIVE INGREDIENTS

Chlorhexidine Gluconate...............................2%
Ketoconazole..................................................1%

ANTIBACTERIAL & ANTIFUNGAL MEDICATED SHAMPOO For Dogs & Cats

DITCH THE ITCH!

Kiss itch and irritation goodbye for your scratchy pets. Treatment is as easy as lather, rinse and soothe. Skin conditions that are responsive to Ketoconazole and Chlorhexidine stand no chance against this powerful formula. Vitamin E and essential fatty acids follow close behind to ensure that treated skin is nourished.

INACTIVE INGREDIENTS

Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Decyl Glucoside, Glycolic Acid, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

PRECAUTIONS

Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Not for otic use. Wash hands after using.

DIRECTIONS

Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow shampoo to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

CAUTIONS

If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

STORAGE

Store at controlled room temperature.

Contains chlorhexidine & ketoconazole
Freshens & deodorizes
Treatment for dry, itchy irritated skin
Removes yeast, bacteria, fungus & ringworm

GENTLE ON SKIN
CHOSEN BY TOP VETS
FOR DOGS AND CATS

ALPHA PAW
Questions or Comments:
Call (800) 363-5458
www.alphapaw.com
Alpha Paw LLC, Las Vegas NV 89139

Packaging

Package 473mL

Package 473mL

ANTIBACTERIAL ANTIFUNGAL MEDICATED 
chlorhexidine gluconate, ketoconazole shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86175-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Product Characteristics
Colororange (pink) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86175-002-16473 mL in 1 BOTTLE, PLASTIC
2NDC:86175-002-321 in 1 PACKAGE
2473 mL in 1 BOTTLE, PLASTIC; Number of Units = 2
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/03/2022
Labeler - Alpha Paw Inc (117036685)
Establishment
NameAddressID/FEIBusiness Operations
Tropichem Research Labs, LLC dba Vetio603123068manufacture
Establishment
NameAddressID/FEIBusiness Operations
Garonit Pharmaceutical, Inc800875106api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Unilab Chemicals and Pharmaceuticals Private Limited915893696api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Cadila Pharmaceuticals Limited916130698api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Piramal Pharma Limited919067108api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Sharon Bio-Medicine Limited675472749api manufacture

Revised: 3/2023
Document Id: c62ac1ec-0d31-4f91-9c5c-a94051bb499c
Set id: 85f5d32f-3b37-4ad7-b22e-e2f9443ef938
Version: 1
Effective Time: 20230330
 
Alpha Paw Inc