Label: HYDROCORTISONE 1%- hydrocortisone ointment
- NDC Code(s): 69396-017-05, 69396-017-20
- Packager: Trifecta Pharmaceuticals Usa Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- Official Label (Printer Friendly)
- DRUG FACTS
- Active ingredient
- Purpose
- Keep out of the reach of children.
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Uses
temporary 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
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Warnings
● for external use only ● avoid contact with the eyes
● do not put this product into the rectum by using fingers or any mechanical device or applicator
● Stop using this product and ask a doctor ● in case of bleeding
● if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
● before you begin using any other hydrocortisone product
Do not use this product and ask a doctor
● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age
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
● do not put this product into the rectum by using fingers or any mechanical device or applicator
● children under 12 years of age: consult a doctor
Before using any medication, read all label directions. Keep this carton. It contains important information. -
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
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE 1%
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-017 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 LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-017-20 1 in 1 BOX 04/09/2016 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-017-05 1 in 1 BOX 08/23/2016 2 15 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 04/09/2016 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)
