Label: HYDROCORTISONE PLUS- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-0063-06 - Packager: Walgreens
- 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 February 22, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
- temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external genital and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
- temporary relief of itching associated with minor skin irritations and rashes due to
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Warnings
For external use only
Do not use
- in the eyes
- by putting this product into the rectum by using fingers or any mechanical device or applicator
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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. consult 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: consult a doctor
- Other information
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Inactive ingredients
aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 45g Tube Carton
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE PLUS
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0063 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 chamomile flower oil (UNII: 60F80Z61A9) citric acid monohydrate (UNII: 2968PHW8QP) corn oil (UNII: 8470G57WFM) glycerin (UNII: PDC6A3C0OX) glyceryl monostearate (UNII: 230OU9XXE4) isopropyl palmitate (UNII: 8CRQ2TH63M) maltodextrin (UNII: 7CVR7L4A2D) methylparaben (UNII: A2I8C7HI9T) mineral oil (UNII: T5L8T28FGP) paraffin (UNII: I9O0E3H2ZE) petrolatum (UNII: 4T6H12BN9U) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) stearyl alcohol (UNII: 2KR89I4H1Y) vitamin A (UNII: 81G40H8B0T) cholecalciferol (UNII: 1C6V77QF41) alpha-tocopherol (UNII: H4N855PNZ1) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0063-06 1 in 1 CARTON 1 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 06/01/2010 Labeler - Walgreens (008965063) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(0363-0063)
