DAVIS MICONAZOLE- miconazole nitrate shampoo

Davis Miconazole by

Drug Labeling and Warnings

Davis Miconazole by is a Animal medication manufactured, distributed, or labeled by Davis Manufacturing and Packaging Inc, Vanessa Solis, Davis Manufacturing and Packaging inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Davis Miconazole Shampoo with 2% Miconazole Nitrate is specifically formulated for dermatological conditions associated with fungal infections such as ringworm, superficial skin infections caused by yeast and scaling due to seborrhea. Made with rich emollients, it penetrates the coat and skin and locks in needed moisture while helping to provide soothing relief. Davis Miconazole Shampoo is free from dyes and fragrances that could cause further irritation or reactions.

SPL UNCLASSIFIED SECTION

MADE IN THE USA

 Davis Manufacturing

541 Proctor Avenue

Scottdale, GA 30079

www.davismfg.com

Product No. MS12   Rev 0712

ACTIVE INGREDIENT

Active Ingredient: Miconazole Nitrate 2.0% 

INACTIVE INGREDIENT

Inactive Ingredients: Purified Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Lauramide DEA, Colloidal Oatmeal, Ethylene Glycol Monostearate, Aloe Vera, PEG Distearate, Methylchloroisothiazolinone (and) Methylisothiazolinone

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE Wet coat thoroughly with warm water. Apply shampoo to head and ears, then lather. Do not get shampoo into eyes. Repeat procedure with neck, chest, middle and hindquarter, finishing with legs. Allow shampoo to soak in for 10 minutes. To prevent ingestion, do not allow animal to lick while bathing. Rinse thoroughly with water. Repeat twice weekly until symptoms subside, then weekly, or as directed by a veterinarian.

SPL UNCLASSIFIED SECTION

If desired follow the Davis Miconazole Shampoo bath with one using Davis Chlorhexidine Shampoo or make your own Miconazole/Chlorhexidine Shampoo by premixing Davis Miconazole shampoo and Davis Chlorhexidine Shampoo.

PRECAUTIONS

Precautions: Avoid contact with eyes and mucous membranes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately contact your veterinarian.

PRINCIPAL DISPLAY PANEL

Davis Veterinary Products
Miconazole Shampoo
With 2% Miconazole Nitrate
For Dogs, Cats, Puppies and Kittens

Therapeutic formula includes Colloidal Oatmeal to soothe damaged skin while helping to relieve symptoms of fungal infections

1 Gallon (3.785 Liters)

PRINCIPAL DISPLAY PANEL

Davis Veterinary Products
Miconazole Shampoo
With 2% Miconazole Nitrate
For Dogs, Cats, Puppies and Kittens

Therapeutic formula includes Colloidal Oatmeal to soothe damaged skin while helping to relieve symptoms of fungal infections

INGREDIENTS AND APPEARANCE

DAVIS MICONAZOLE 
miconazole nitrate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 62570-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
OATMEAL (UNII: 8PI54V663Y)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
GLYCOL STEARATE (UNII: 0324G66D0E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62570-070-12	355 g in 1 BOTTLE
2	NDC: 62570-070-01	3785 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/14/2017

Labeler - Davis Manufacturing and Packaging Inc (106680523)

Registrant - Vanessa Solis (106680523)

Establishment
Name	Address	ID/FEI	Business Operations
Davis Manufacturing and Packaging inc		106680523	api manufacture