Label: HYDROCORTISONE CREAM- hydrocortisone cream
- NDC Code(s): 69396-096-16
- Packager: Trifecta Pharmaceuticals USA
- 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 September 27, 2023
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- Download DRUG LABEL INFO: PDF XML
- 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
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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 not final part348 01/13/2022 Labeler - Trifecta Pharmaceuticals USA (079424163)
