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

if you have vaginal discharge.  Consult a doctor

When using this product:

Avoid contact with the eyes

Do not use more than directed unless told to do so by a doctor.

Do not put this product into the rectum by using fingers or any mechanical device or applicator

If rectal bleeding occurs, consult a doctor promptly

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 and do not begin use of any other hydrocortisone product unless you have asked a doctor.

Directions

for itching of skin irritation, inflammation and rashes:

For external anal and genital itching, adults and children 12 years of age and older:

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

Hydrocortisone Cream

CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-097
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:51824-097-0128 g in 1 TUBE; Type 0: Not a Combination Product01/01/2024
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: c1bf9857-8467-4e90-920e-c0748386ed55
Set id: d04e473d-8bbc-475c-a0b1-ca5eed67fbc7
Version: 2
Effective Time: 20231013
 
New World Imports, Inc