Label: HYDROCORTISONE CREAM- hydrocortisone cream
- NDC Code(s): 69396-096-16
- Packager: Trifecta Pharmaceuticals USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Uses
For temporarily rellief of itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- seborrheic dermatitis
- psoriasis
- insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- external feminine, genital and anal itching
Other use of this product should be only under the advice and supervision of a doctor
- Keep out of reach of children
- Warnings
- Stop using this product and ask a doctor
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When using this product
When using this product
- avoid contact with the eyes
- do not begin the use of any other hydrocortisone product unless you have consulted a doctor
- for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
- Do not use
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Directions
Adults and Children 2 years 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 and anal itching
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children under 12 years of age with external and anal itching: Consult a doctor.
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Inactive Ingredients
Aloe barbadensis leaf juice, Cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, glycerin, Glycerol Stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2-Phenoxyethanol, Polysorbate 80, Propylene Glycol, purified water, Stearic Acid, Trisodium citrate dihydrate, Vitamin E.
- Other Information
- Other Information
- Package Label
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE CREAM
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-096 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 MALTODEXTRIN (UNII: 7CVR7L4A2D) EDETIC ACID (UNII: 9G34HU7RV0) GINGER OIL (UNII: SAS9Z1SVUK) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STEARIC ACID (UNII: 4ELV7Z65AP) METHYL GLUCETH-20 (UNII: J3QD0LD11P) 3-METHYLPENTADECANE (UNII: X64R3JC095) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLPARABEN (UNII: 14255EXE39) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-096-16 454 g in 1 JAR; Type 0: Not a Combination Product 01/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/13/2022 Labeler - Trifecta Pharmaceuticals USA (079424163)
