Label: HYDROCORTISONE D- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 40002-003-02, 40002-003-03 - Packager: NexMed (USA), Inc.
- 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 August 19, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Uses
- 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, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
- for external genital, feminine and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
- Warnings
- When using this product
- Stop use and ask a doctor if
- Do not use
- Keep out of reach of children
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Directions
- For 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, consult a doctor
- Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- Gently dry by patting or blotting toilet tissue or a soft cloth before application of this product
- Children under 12 years of age: for external itching consult a doctor
- Other information
- Inactive Ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE D
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40002-003 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 Citric Acid Monohydrate (UNII: 2968PHW8QP) Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40002-003-02 1 in 1 CARTON 1 NDC:40002-003-03 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/19/2011 Labeler - NexMed (USA), Inc. (031710528) Registrant - NexMed (USA), Inc. (031710528)