Allermyl: Product Information

ALLERMYL- piroctone olamine shampoo
Virbac AH, 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.

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 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

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)

image description
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ALLERMYL piroctone olamine shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51311-071
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIROCTONE OLAMINE (PIROCTONE) PIROCTONE OLAMINE 0.5 mg in 1 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL
COCO-BETAINE
MANNOSE, D-
PEUMUS BOLDUS LEAF
WATER
SODIUM LAURETH SULFATE
XANTHAN GUM
LAURETH-2
METHYLPROPANEDIOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-071-16 1 CONTAINER in 1 CARTON contains a CONTAINER
1 473 mg in 1 CONTAINER This package is contained within the CARTON (51311-071-16)
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 Operations
Virbac Corporation 829166276 manufacture
Establishment
Name Address ID/FEI Operations
Kumar Organic Products Limited 918155912 api manufacture

Revised: 07/2018 Virbac AH, Inc.

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