CAREALL HYDROCORTISONE  MAXIMUM STRENGTH- hydrocortisone cream 
New World Imports, Inc

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Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Keep out of reach of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Uses

Warnings

For external use only

Do not use: For the treatment of diaper rash.  Consult a doctor

When using this product:

Avoid contact with the eyes

Do not begin use of any other hydrocortisone product unless you have consulted a doctor

Stop use and ask a doctor if:

Condition worsens

Symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

Hydrocortisone Packet Box Label

CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Propylene Glycol (UNII: 6DC9Q167V3)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Mineral Oil (UNII: T5L8T28FGP)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
Chlorocresol (UNII: 36W53O7109)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (White Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-098-14144 in 1 BOX01/01/2024
1NDC:51824-098-09.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:51824-098-2525 in 1 BOX01/01/2024
2NDC:51824-098-09.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/01/2024
Labeler - New World Imports, Inc (075372276)

Revised: 10/2023
Document Id: 089fac68-12b4-4998-b44b-858016f68d2e
Set id: e2df8130-e7c8-4fde-a6d6-c71378991213
Version: 2
Effective Time: 20231013
 
New World Imports, Inc