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
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 17, 2023
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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
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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 not final part348 04/09/2016 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)
