Hydrocortisone by Medrock Pharmacy LLC / RT FORMULATORS LLC HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Medrock Pharmacy LLC, RT FORMULATORS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Hydrocortisone 1%

Purpose

Anti-itch, Topical Analgesic

Indications:

Helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin and lips and offers temporary relief of minor skinirritations and inflammation due to 

• Weather
• Allergies
• Cold sores
• Eczema
• Cosmetics

Other uses of this product should only be under the advice or supervision of a doctor.

Warnings:

• for external use only
• Avoid contact with eyes  

Stop use and ask a physician:

• if condition worsens or symptoms persist for 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a physician

Keep out of reach of children.

Directions:

• Adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
• Children under 2 years of age: consult a physician

For external anal itching:

• Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Inactive ingredients:

Ricinus Communis (Castor) Seed Oil  Beeswax  Helianthus Annuus (Sunflower) Seed Oil  Prunus Amygdalus Dulcis (Sweet Almond) Oil
Theobroma Cacao (Cocoa) Seed Butter  Butyrospermum Parkii (Shea) Butter  Simmondsia Chinensis (Jojoba) Seed Oil
Tocopheryl Acetate

Questions or Comments:

• Call 1-833-633-7625
• Email us: support@medrockpharmacy.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85402-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
BEESWAX (UNII: 2ZA36H0S2V)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85402-001-01	1 in 1 CARTON	07/01/2025
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/01/2025

Labeler - Medrock Pharmacy LLC (068047775)

Registrant - RT FORMULATORS LLC (114799346)

Establishment
Name	Address	ID/FEI	Business Operations
RT FORMULATORS LLC		114799346	manufacture(85402-001)