MEDI-FIRST- hydrocortisone acetate cream

MEDI-FIRST by

Drug Labeling and Warnings

MEDI-FIRST by is a Otc medication manufactured, distributed, or labeled by Orazen Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• for the temporary relief of itching associated with minor skin irritation,inflammation and rashed due to eczema, insect bites, poison ivy, poison oak,poison sumac, soaps, detergents, cosmetics,jewelry, sebortheic dermatitis, psoriasis and scrapes
• other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• for treatment of diaper rash
• in eyes
• for feminine itching

Stop use and ask a doctor if

• condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
• you begin use of any other hydrocortisone product
• bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
• ​children under 12 years of age: for external anal itching, consult a doctor
• children under 2 years of age: do not use, consult a doctor
• adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad

(continued on side panel)

• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Other information

• store at room temperature (do not freeze)
• tamper evident, do not use any opened or torn packets

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolatum, phenoxyethanol, water

Questions or comments?

1-800-634-7680

Package Labeling:

INGREDIENTS AND APPEARANCE

MEDI-FIRST 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-018-03	144 in 1 BOX	02/17/2023
1	NDC: 71927-018-01	0.9 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/17/2023

Labeler - Orazen Inc (080916640)