Label: HYDROCORTISONE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58988-0019-1 - Packager: Promex, LLC
- 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 March 9, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Uses
- temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:
- eczema
- insect bites
- poison ivy, oak, or sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- temporarily relieves external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
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Warnings
For external use only
Do not use
- in the genital area if you have a vaginal discharge.
- Consult a doctor for the treatment of diaper rash
When using this product
- avoid contact with eyes
- do not use more than directed unless told to do so by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
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Directions
- for itching of skin irritation, inflammation, and rashes:
- 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: Ask a doctor
- for external anal and genital itching, adults:
- when practical, clean the affected area with mild soap and water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: Ask a doctor
- Other information
- Inactive Ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58988-0019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58988-0019-1 1 in 1 BOX 11/15/2013 1 28.35 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/15/2013 Labeler - Promex, LLC (789974388)
