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.

----------

AtopiCream HC Leave-On Conditioner Plus Detangling Anti-Itch Skin Repair for Animals

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.

AtopiCream HC Leave-On Conditioner Plus Detangling Anti-Itch Skin Repair for Animals

8 fl oz (240 ml)

NDC 86030-095-01

Label

ATOPICREAM HC 
hydrocortisone lotion
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86030-095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86030-095-01240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/31/2017
Labeler - VetriMax Veterinary Products, LLC (064087564)
Establishment
NameAddressID/FEIBusiness Operations
Salvona Technologies LLC113437946manufacture
Establishment
NameAddressID/FEIBusiness Operations
Symbiotec Pharmalab Private Limited677604336api manufacture

Revised: 11/2022
Document Id: 55fe0f06-4bb8-46fd-9133-a042289fd964
Set id: c17ed635-468e-4310-afae-5f33512158ac
Version: 5
Effective Time: 20221110
 
VetriMax Veterinary Products, LLC