Label: HYDROCORTISONE CREAM- hydrocortisone cream
- NDC Code(s): 69396-028-01, 69396-028-02, 69396-028-33, 69396-028-44
- Packager: Trifecta Pharmaceuticals USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 28, 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, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external 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
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Warnings
- for external use only
- avoid contact with eyes
- do not put this product into the rectum by using fingers or any mechanical device or applicator
For External Anal Itching Users:
- do not exceed the recommended daily dosage unless directed by a doctor
- in case of bleeding, consult a doctor promptly
- children under 12 years of age: consult a doctor
Before using any medication, read all label directions. Keep this carton as it contains important information
- Stop using this product and ask a doctor
- Do not use this product and ask a doctor
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Directions
- 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 applying
- adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
- children under 12 years of age: do not use, consult a doctor
- Inactive Ingredients
- Other Information
- Other Information
- Package Label
- Label
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE CREAM
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-028 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 GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PETROLATUM (UNII: 4T6H12BN9U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) ETHYLPARABEN (UNII: 14255EXE39) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-028-01 1 in 1 BOX 04/07/2017 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-028-02 1 in 1 BOX 04/07/2017 2 56 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69396-028-44 4 in 1 BOX 02/07/2024 3 28.4 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:69396-028-33 3 in 1 BOX 02/28/2024 4 28.4 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 04/07/2017 Labeler - Trifecta Pharmaceuticals USA (079424163)