DAVIS MELALEUCA- melaleuca shampoo

Davis Melaleuca by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

Davis Melaleuca Shampoo helps provide soothing relief for pets suffering from dry, itchy and irritated skin. It is formulated with a synergistic combination of natural oils, penetrants and emollients featuring the soothing action of Melaleuca Alternifolia Oil. This natural ingredient, derived from the Australian Tea Tree, provides rapid action and deep skin penetration to help revive the pet's coat and skin.  The addition of Vitamin E, Wheat Germ Oil, Rosemary, and Coconut Oil assists in nourishing the skin and rebuilding a healthy coat. Davis Melaleuca Shampoo is effective, yet mild and may even be used for routine shampooing.

SPL UNCLASSIFIED SECTION

Environment Friendly

MADE IN THE USA

Davis Manufacturing

541 Proctor Avenue

Atlanta/Scottdale, GA 30079

www.davismfg.com

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, finish with legs. Rinse thoroughly.

WARNINGS AND PRECAUTIONS

Some pets have unusually sensitive skin. Discontinue use if irritation develops.

DOSAGE FORMS & STRENGTHS

DILUTION RATES                                                        PARTS WATER                                               PARTS SHAMPOO 

GENERAL USE	5	1
MILD CONDITIONS	3	1
SEVER CONDITIONS	1	1

INACTIVE INGREDIENT

INGREDIENTS: AMMONIUM LAURYL SULFATE, TEA TREE OIL, COCOMIDOPROPYL BETAINE, COCONUT BASED LATHERING AGENT, PROPYLENE GLYCOL, COSMETIC GRADE PRESERVATIVE, GREEN DYE, pH ADJUSTER, PURIFIED WATER

KEEP OUT OF REACH OF CHILDREN

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN 

PRINCIPAL DISPLAY FOR 355 ML

DAVIS VETERINARY PRODUCTS

MELALEUCA SHAMPOO

WITH VITAMIN E AND ROSEMARY

FOR DOGS, CATS, PUPPIES AND KITTENS

FOR CONDITIONS ASSOCIATED WITH SEBORREA DERMITIS, BACTERIA AND FUNGI

12 FL. OZ. (355 ML)

PRINCIPAL DISPLAY PANEL

DAVIS VETERINARY PRODUCTS

MELALEUCA SHAMPOO

WITH VITAMIN E AND ROSEMARY

FOR DOGS, CATS, PUPPIES AND KITTENS

FOR CONDITIONS ASSOCIATED WITH SEBORREA DERMITIS, BACTERIA AND FUNGI

1 GALLON (3.785 LITERS)

INGREDIENTS AND APPEARANCE

DAVIS MELALEUCA 
melaleuca shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 62570-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	0.7239 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62570-061-12	355 g in 1 BOTTLE
2	NDC: 62570-061-01	3785 g in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/31/2018

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