MEDI-FIRST- hydrocortisone acetate cream 
Orazen Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MEDI-FIRST
Hydrocortisone Cream 1%

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

(continued on side panel)

Other information

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:

image of pouch label

image of box label

MEDI-FIRST 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-018-03144 in 1 BOX02/17/2023
1NDC:71927-018-010.9 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/17/2023
Labeler - Orazen Inc (080916640)

Revised: 2/2023
Document Id: f4e7135e-042f-9862-e053-2a95a90aec08
Set id: f4e7135e-042e-9862-e053-2a95a90aec08
Version: 1
Effective Time: 20230217
 
Orazen Inc