Advanced Hydrocortisone

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Ultra Seal Corporation
NDC Code: 42213-370

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 Ingredients (in each gram) Hydrocortisone USP-10 mg

Purpose: Antipruritic (Anti Itch)

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema,insect bites, poison ivy, poison oak, poison sumac, detergents, cosmetics, jewelry, saborrheic dermatitis, psoriasis and scrapes. For external feminine, genital, 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.

Consult a doctor before use if :you have a vaginal discharge (for external feminine itching).  For external itching, do not exceed the recommended daily dosage or if bleeding occurs. If condition worsens or symptoms persist more than 7 days or clear up and occur again within a few days.

When using this product:  Avoid contact with eyes, do not put this product into rectum using fingers or any mechanical device or applicator

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

Directions:  For adults and children 2 years of age and older: Apply to affected area not more than 3-4 times daily
Children under 2 years of age: Do not use, consult a doctor.
Adults for external itching, when practical, cleanse the affected area with mild soap and warm water and rinse th
thoroughly or by patting or blotting with an appropriate cleansing pad
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 12 years of age-For external anal itching, consult a doctor

Inactive Ingredients:  Citric Acid, Glycerin, Glycerol Stearate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Titanium Dioxide

MM1

Keep out of reach of children

ADVANCED HYDROCORTISONE  
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-370
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
GLYCERYL MONOSTEARATE 
GLYCERIN 
PETROLATUM 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:42213-370-090.9 g in 1 PACKET
2NDC:42213-370-80144 PACKET (PACKET) in 1 BOX
2NDC:42213-370-341.5 g in 1 PACKET
3NDC:42213-370-2828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/05/2011
Labeler - Ultra Seal Corporation (085752004)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture

Revised: 04/2011
 
Ultra Seal Corporation

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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