Label: HYDROCORTISONE- drs. hydrocortisone cream
- NDC Code(s): 80489-001-01, 80489-001-02
- Packager: OL PHARMA TECH,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 21, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK YOUR DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
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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, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
drs. hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80489-001 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 CETEARETH-12 (UNII: 7V4MR24V5P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MINERAL OIL (UNII: T5L8T28FGP) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80489-001-01 1 in 1 CARTON 01/01/2021 1 28.3 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:80489-001-02 1 in 1 CARTON 01/01/2021 2 49.5 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 Drug M016 01/01/2021 Labeler - OL PHARMA TECH,LLC (021170377) Registrant - OL PHARMA TECH,LLC (021170377) Establishment Name Address ID/FEI Business Operations OL PHARMA TECH,LLC (Drs. pharmacy) 021170377 manufacture(80489-001)