MedPath

Paw Science HYDROCORTISONE

Paw Science HYDROCORTISONE LOTION

Approved
Approval ID

c73dfc4d-a7d1-47d0-9f2a-bb9304931a0d

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Aug 27, 2025

Manufacturers
FDA

Pet Science LLC

DUNS: 119280769

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrocortisone Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code86207-003
Product Classification
G
Generic Name
Hydrocortisone Acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (16)

HYDROCORTISONE ACETATEActive
Quantity: 0.5 g in 100 mL
Code: 3X7931PO74
Classification: ACTIB
ALOE VERA LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SYNTHETIC BEESWAXInactive
Code: 08MNR5YE2R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/12/2025

Packaging

Paw Science HYDROCORTISONE

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/27/2025

Uses

• Helps soothe:
• flea bites • dermatitis • skin irritations • inflammations • eczema • itching

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/12/2025

MEDICATED FORMULA

REDUCES ITCHING + SWELLING

FORMULATED FOR DOGS & CATS

SEA KELP SCENT

MADE IN THEUSA WITH GLOBALLY SOURCED INGREDIENTS

PRODUCT INFORMATION

Paw Science Hydrocortisone Lotion soothes flea bites, dermatitis, skin irritations, inflammations, eczema, and itching.

FOR BEST RESULTS:
1. Pre-bathe with a mild shampoo and dry thoroughly.
2. Part the coat to expose the affected area.
3. Apply a thin layer of the lotion directly to the affected area.
4. Allow the area to air dry.
5. For long-haired breeds, it may be necessary to clip the hair around the affected area to expose skin.
6. Wash your hands after use.
7. Use 3 to 4 times daily, or as directed by your veterinarian, until condition improves.
8. If undue skin irritation develops or increases, discontinue use and consult your veterinarian.

Questions? Email us at support@pawscience.com

Manufactured for Paw Science
5319 University Dr. #114
Irvine, CA 92612 | Ph: 949.409.7299
www.pawscience.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/27/2025

Active Ingredient

Hydrocortisone Acetate
(Equivalent to Hydrocortisone 0.5%)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/27/2025

Purpose

Antipruritic (Anti-Itch)
Anti-Inflammatory

WARNINGS SECTION

LOINC: 34071-1Updated: 8/27/2025

Warnings

For use on dogs and cats only.

Keep out of reach of children and pets.
Avoid contact with eyes or other mucous membranes. If eye contact occurs, rinse thoroughly with water and seek medical attention if irritation persists.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/27/2025

Directions

• Apply to affected area not more than 3 to 4 times daily.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/27/2025

Other Information

• Store at room temperature 68-77°F (20-25°C).

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/27/2025

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, Fragrance, Isopropyl Myristate, Mineral Oil, Phenoxyethanol, Potassium Sorbate, Propanediol, Sodium Benzoate, Sodium Borate, Stearic Acid, Synthetic Beeswax, Water

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Paw Science HYDROCORTISONE - FDA Drug Approval Details