AtopiCream HC: Product Information

ATOPICREAM HC- hydrocortisone lotion
VetriMax Veterinary Products, LLC

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:

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

AtopiCream HC Therapeutic Skin Repair for Animals with Hydrocortisone

8 fl oz (240 ml)

Label
(click image for full-size original)
ATOPICREAM HC
hydrocortisone lotion
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86030-095
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) 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)
ALOE VERA LEAF
WATER
ARGININE
BEHENTRIMONIUM METHOSULFATE
BUTYLENE GLYCOL
SHEA BUTTER
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
CHOLESTEROL
DIMETHICONE
EDETATE DISODIUM ANHYDROUS
ETHYLHEXYLGLYCERIN
CANDELILLA WAX
GLYCERIN
GLYCERYL MONOSTEARATE
SUNFLOWER OIL
STARCH, CORN
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE
ISOMERIZED SAFFLOWER ACID
LACTIC ACID, UNSPECIFIED FORM
PALMITIC ACID
PHENOXYETHANOL
POLYSORBATE 20
POTASSIUM CHLORIDE
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
SODIUM CHLORIDE
SODIUM HYDROXIDE
SODIUM LAUROYL GLUTAMATE
SODIUM PYRROLIDONE CARBOXYLATE
SODIUM PHOSPHATE
SQUALENE
STEARIC ACID
STEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86030-095-01 240 mL in 1 BOTTLE None
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 Operations
Salvona Technologies LLC 113437946 manufacture
Establishment
Name Address ID/FEI Operations
Symbiotec Pharmalab Private Limited 677604336 api manufacture

Revised: 11/2019 VetriMax Veterinary Products, LLC

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