Label: HYDROCORTISONE CREAM- hydrocortisone cream
- NDC Code(s): 69396-147-01
- Packager: Trifecta Pharmaceuticals USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 20, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Uses
Temporarily relieves 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 uses of this product should be only under the advice and supervision of a doctor
- Keep out of reach of children
- Warnings
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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 ithcing
- 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 anal itching, consult a doctor.
- Do Not Use
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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 fingersor any mechanical device or applicator.
- Stop Using this product and ask a doctor if
- Questions
- Inactive Ingredients
- Other Information
- Other Information
- Label
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE CREAM
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-147 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 SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 60 (UNII: CAL22UVI4M) PETROLATUM (UNII: 4T6H12BN9U) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-147-01 1 in 1 BOX 03/01/2024 1 28 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 M017 02/20/2024 Labeler - Trifecta Pharmaceuticals USA (079424163)
