Label: HYDROCORTISONE ointment
- NDC Code(s): 69396-003-20, 69396-003-33, 69396-003-44
- Packager: TRIFECTA PHARMACEUTICALS USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 29, 2024
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- Official Label (Printer Friendly)
- 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. -
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 doctorBefore using any medication, read all label directions. Keep this carton. It contains important information.
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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 INGREDIENT
- Other Information
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-003 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) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-003-20 1 in 1 BOX 06/15/2017 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-003-44 4 in 1 BOX 02/28/2024 2 28.4 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69396-003-33 3 in 1 BOX 02/29/2024 3 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 03/10/2015 Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163) Registrant - Trifecta Pharmaceuticals USA (079424163)
