Label: ATOPICREAM HC- hydrocortisone lotion
- NDC Code(s): 86030-095-01
- Packager: VetriMax Veterinary Products, LLC
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated November 10, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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:
- Precautions:
- Active Ingredients:
-
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.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ATOPICREAM HC
hydrocortisone lotionProduct 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) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) 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
