ATOPICREAM HC- hydrocortisone lotion

AtopiCream HC by

Drug Labeling and Warnings

AtopiCream HC by is a Animal medication manufactured, distributed, or labeled by VetriMax Veterinary Products, LLC, Salvona Technologies LLC, Symbiotec Pharmalab Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses:

For veterinary use only. AtopiCream HC™ provides temporary relief of
itching, skin irritation and rashes due to allergic response, contact allergens
and insect bites. AtopiCream HC™ contains hydrocortisone to reduce itching and
other ingredients including ceramides that promote healthy skin regeneration in
animals.

Directions:

For dogs, cats and horses 6 months and older. Apply to affected area 2 to 3 times daily, or as directed by your veterinarian. Rub lotion completely into skin. For best results, gently cleanse the affected area with Command™ Shampoo prior to use.

Precautions:

For external use only. Keep out of reach of children. Do not use in conjunction with other products containing hydrocortisone while using this product. Avoid contact with eyes. Do not ingest. Consult your veterinarian if condition worsens or persists. Wash hands after use.

Active Ingredients:

Hydrocortisone 1.0%

Inactive Ingredients:

Acrylates/Dimethylaminoethyl Methacrylate Copolymer, Acrylates/Ethylhexyl Acrylate Copolymer, Aloe Barbadensis Leaf Juice, Aqua/Water, Arginine, Behentrimonium Methosulfate, Butylene Glycol, Butyrospermum Parkii (Shea Butter), Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Glyceryl Stearate , Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Corn Starch, Hydroxyethyl Behenamidopropyl Dimonium, Chloride, Hydroxypropyl Bispalmitamide MEA, lsomerized Safflower Acid, Lactic Acid, Palmitic Acid, Phenoxyethanol, Polyacrylate-13, Polyisobutene, Polysorbate 20, Potassium Chloride Potassium Phosphate, Sodium Chloride, Sodium Hydroxide, Sodium Lauroyl Glutamate, Sodium PCA, Sodium Phosphate, Squalene, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

AtopiCream HC Therapeutic Skin Repair for Animals with Hydrocortisone

8 fl oz (240 ml)

INGREDIENTS AND APPEARANCE

ATOPICREAM HC 
hydrocortisone lotion

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86030-095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL METHACRYLATE/ETHYLHEXYL ACRYLATE/METHACRYLIC ACID/DIMETHYLAMINOETHYL METHACRYLATE/STYRENE/HYDROXYPROPYL METHACRYLATE COPOLYMER (60000 MW) (UNII: B2U8V9E232)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARGININE (UNII: 94ZLA3W45F)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)
ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SQUALENE (UNII: 7QWM220FJH)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86030-095-01	240 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/31/2017

Labeler - VetriMax Veterinary Products, LLC (064087564)

Establishment
Name	Address	ID/FEI	Business Operations
Salvona Technologies LLC		113437946	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Symbiotec Pharmalab Private Limited		677604336	api manufacture