CAREALL HYDROCORTISONE  MAXIMUM STRENGTH- hydrocortisone acetate cream 
New World Imports, 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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Drug Facts

Hydrocortisone Acetate 1%

Anti-Itch

If swallowed, get medical help or contact a Poison Control Center immediately.

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

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 toilet 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

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CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-002
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
Propylene Glycol (UNII: 6DC9Q167V3)  
Petrolatum (UNII: 4T6H12BN9U)  
Mineral Oil (UNII: T5L8T28FGP)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
Sodium Metabisulfite (UNII: 4VON5FNS3C)  
Chlorocresol (UNII: 36W53O7109)  
Edetate Disodium (UNII: 7FLD91C86K)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (White Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-002-0128 g in 1 TUBE; Type 0: Not a Combination Product08/30/201012/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/30/201012/31/2019
Labeler - New World Imports, Inc (075372276)

Revised: 10/2019
 
New World Imports, Inc