ZCORT ULTRA- hydrocortisone acetate 1% cream 
RxDino, LLC

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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Drug Facts
Active Ingredients

Hydrocortisone Acetate 1%

Purpose

Anti-Itch

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

Warnings

For external use only

DO NOT USE

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR

KEEP OUT OF REACH OF CHILDREN

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

Directions

FOR ITCHING OF SKIN IRRITATION, INFLAMMATION, AND RASHES

FOR EXTERNAL ANAL AND GENITAL ITCHING, ADULTS

Other Information

Contents filled by weight, not volume

Inactive Ingredients

Aloe Barbadenis Leaf Extract, Cetearyl Alcohol, Cocos Nucifera Oil, Dehydroepiandrosterone (DHEA), Emulsifying Wax, Glycerin, Helianthus Annuus Seed Oil, Phenoxyethanol, Simmondsia Chinensis Seed Oil, Stearic Acid, Tocopherol, Water, Xanthan Gum

Front Display Panel and Back Card

NEW!

FORMULATED TO HEAL ITCH AND PROTECT COLLAGEN

STEROID POWER

FAST ACTING

UNIQUE PATENTED FORMULA

ZCort ULTRA+ ANTI-ITCH CREAM

NET WT 0.5 OZ (15g)

ACTIVE INGREDIENT: HYDROCORTIZONE 1% WITH DHEA

see zcortfront.jpg

Front Display Panel

ZCort Ultra+ ANTI-ITCH CREAM BACK CARD

see zcortbackbox.jpg

Back Card

ZCORT  ULTRA
hydrocortisone acetate 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81335-532
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
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PRASTERONE (UNII: 459AG36T1B)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81335-532-1515 g in 1 BOX; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2021
Labeler - RxDino, LLC (117804297)

Revised: 1/2023
Document Id: ea635da8-e3b7-10d3-e053-2995a90aca8f
Set id: b68f8ada-58e8-e8e4-e053-2a95a90ab02d
Version: 3
Effective Time: 20230105
 
RxDino, LLC