Label: HYDROCORTISONE ointment
- NDC Code(s): 69396-149-01
- Packager: TRIFECTA PHARMACEUTICALS USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 11, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep out of the reach of children
-
Uses
temporary relief of 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 feminine genital and anal itching
other uses of this product should be only under the advice and supervision of a doctor. - 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 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 anal itching: consult a doctor.
- INACTIVE INGREDIENT
- Do Not Use
- Other Information
- Distributed By
- Stop using this product and ask a doctor if
-
When Using This Product
- Avoid contact with 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.
- Questions:
- Packaging
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-149 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:69396-149-01 1 in 1 BOX 03/14/2024 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 03/10/2024 Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163) Registrant - Trifecta Pharmaceuticals USA (079424163)
