ALLERMYL- piroctone olamine shampoo

Allermyl by

Drug Labeling and Warnings

Allermyl by is a Animal medication manufactured, distributed, or labeled by Virbac AH, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

USE IN SPECIFIC POPULATIONS

USES: ALLERMYL® Shampoo with S-I-S SKIN INNOVATIVE SCIENCE® Technology is a soothing shampoo for the management of allergic skin conditions. Specifically designed to meet the needs of dogs and cats with sensitive and itchy skin. ALLERMYL Shampoo is a unique micro-emulsified formulation which combines ingredients that help:

• Maintain skin barrier integrity

        ◊ Moisturizing and soothing effects (Skin Lipid Complex combination)

• Support healthy skin with S-I-S SKIN INNOVATIVE SCIENCE Technology:

         ◊ Provides micro-organism anti-adhesive effects (Glycotechnology)
         ◊ Promotes natural skin microbial defenses (Defensin technology)

• Promote a healthy microbial balance in animals with allergic skin conditions (Piroctone Olamine)

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Piroctone Olamine 0.5% w/w

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Alkylpolyglucoside, Butylene Glycol, Citric Acid, Coco-Betaine, d-Galactose, d-Mannose, Disodium EDTA, l-Rhamnose, Laureth-2, Methylpropanediol, PEG-90 Glyceryl Isostearate, Peumus boldus Leaf Extract, Purified Water, Skin Lipid Complex (Ceramides, Fatty Acids), Sodium Laureth Sulfate, Spiraea ulmaria Extract, Vitamin F, Xanthan Gum

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE: Shake well before use. Wet the hair coat with water and apply a thin line of shampoo from the base of the neck to the base of the tail. Massage shampoo over pet's body to ensure good contact with the skin. Allow to remain on hair coat for 5 to 10 minutes, then rinse thoroughly with clean water and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reduce to once a week, or as directed by your veterinarian.

WARNINGS AND PRECAUTIONS

CAUTION: For animal use only. For external use only. Avoid contact with eyes or mucous membranes. Not for otic use. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

WARNING: EYE IRRITANT. Avoid contact with eyes. In case of contact, flush eyes with water and seek medical attention if irritation persists. Wash hands after using.

Keep out of reach of children.

STORAGE AND HANDLING

STORAGE: Store at controlled room temperature 59° - 86°F (15° - 30°C).

QUESTIONS?
Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161
1-800-338-3659 us.virbac.com

302242-01

8 14514 02417 5

PRINCIPAL DISPLAY PANEL

Virbac, a pioneer in Veterinary Dermatology, offers a broad range of skin care products tailored to the individual needs of the pet, helping to improve quality of life.

USES: ALLERMYL® Shampoo with S-I-S SKIN IN◊NOVATIVE SCIENCE® Technology is a soothing shampoo for the management of allergic skin conditions. Specifically designed to meet the needs of dogs and cats with sensitive and itchy skin. ALLERMYL Shampoo is a unique micro-emulsified formulation which combines ingredients that help:

• Maintain skin barrier integrity

      ◊Moisturizing and soothing effects (Skin Lipid Complex combination)

•  Support healthy skin with S-I-S SKIN INNOVATIVE SCIENCE Technology:

      ◊Provides micro-organism anti-adhesive effects (Glycotechnology)

      ◊Promotes natural skin microbial defenses (Defensin technology)

• Promote a healthy microbial balance in animals with allergic skin conditions (Piroctone Olamine)

ACTIVE INGREDIENTS: Piroctone Olamine 0.5% w/w

INACTIVE INGREDIENTS: Alkylpolyglucoside, Butylene Glycol, Citric Acid, Coco-Betaine, d-Galactose, d-Mannose, Disodium EDTA, l-Rhamnose, Laureth-2, Methylpropanediol, PEG-90 Glyceryl Isostearate, Peumus boldus Leaf Extract, Purified Water, Skin Lipid Complex (Ceramides, Fatty Acids), Sodium Laureth Sulfate, Spiraea ulmaria Extract, Vitamin F, Xanthan Gum

DIRECTIONS FOR USE: Shake well before use. Wet the hair coat with water and apply a thin line of shampoo from the base of the neck to the base of the tail. Massage shampoo over pet's body to ensure good contact with the skin. Allow to remain on hair coat for 5 to 10 minutes, then rinse thoroughly with clean water and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reduce to once a week, or as directed by your veterinarian.

CAUTION: For animal use only. For external use only. Avoid contact with eyes or mucous membranes. Not for otic use. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

WARNING: EYE IRRITANT. Avoid contact with eyes. In case of contact, flush eyes with water and seek medical attention if irritation persists. Wash hands after using.
Keep out of reach of children.

STORAGE: Store at controlled room temperature 59° - 86°F (15° - 30°C).

QUESTIONS?
Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161
1-800-338-3659 us.virbac.com

302242-01

8 14514 02417 5

NDC: 51311-071-16
Virbac
ALLERMYL®
(PIROCTONE OLAMINE)

MEDICATED SHAMPOO
FOR DOGS AND CATS

FOR MANAGEMENT
OF ALLERGIC
SKIN CONDITIONS

HELPS MAINTAIN SKIN
BARRIER INTEGRITY &
MICROBIAL BALANCE

S>I>S®
>SKIN
>INNOVATIVE
>SCIENCE

SOOTHES &
MOISTURIZES

16 FL. OZ. (473 mL)

INGREDIENTS AND APPEARANCE

ALLERMYL 
piroctone olamine shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51311-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIROCTONE OLAMINE (UNII: A4V5C6R9FB) (PIROCTONE - UNII:R49EFA73Q7)	PIROCTONE OLAMINE	0.5 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
COCO-BETAINE (UNII: 03DH2IZ3FY)
MANNOSE, D- (UNII: PHA4727WTP)
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURETH-2 (UNII: D4D38LT1L5)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-071-16	1 in 1 CARTON
1		473 mg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2018

Labeler - Virbac AH, Inc. (131568396)

Establishment
Name	Address	ID/FEI	Business Operations
Virbac Corporation		829166276	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Kumar Organic Products Limited		918155912	api manufacture