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CAREALL Hydrocortisone Maximum Strength

Dosage form: cream
Ingredients: Hydrocortisone Acetate 1g in 1g
Labeler: New World Imports, Inc
NDC Code: 51824-050

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.

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 immediately.

Uses

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

eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal itching.

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 the treatment of diaper rash.  Ask a doctor

For external genital itching if you have a vaginal discharge.  Ask a doctor

When using this product:

Avoid contact with the eyes

Do not begin use of any other Hydrocortisone product unless you have asked a doctor

For external anal itching do not exceed the recommended daily dosage unless directed by a doctor.  In case of bleeding, consult a doctor promptly.

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

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

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age:

  • do not use.  Ask a doctor.

For external anal itching:

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.  Gently dry by patting or blotting with toliet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching: ask a doctor.

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin

CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone Acetate (Hydrocortisone ) Hydrocortisone Acetate1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Propylene Glycol 
Petrolatum 
Mineral Oil 
Cetostearyl Alcohol 
CETETH-20 
Chlorocresol 
Water 
Product Characteristics
Colorwhite (White Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51824-050-0128 g in 1 TUBE
2NDC:51824-050-09.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/11/2016
Labeler - New World Imports, Inc (075372276)

Revised: 03/2016
 
New World Imports, Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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