Label: ADVANCED HYDROCORTISONE- hydrocortisone cream
- NDC Code(s): 42213-370-09
- Packager: Ultra Seal Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated January 7, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
INDICATIONS & USAGE
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
DOSAGE & ADMINISTRATION
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 INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42213-370 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42213-370-09 0.9 g in 1 PACKET; Type 0: Not a Combination Product 04/05/2011 07/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/05/2011 07/01/2024 Labeler - Ultra Seal Corporation (085752004) Registrant - Ultra Seal Corporation (085752004) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(42213-370)