Label: HYDROCORTISONE ointment
Contains inactivated NDC Code(s)
NDC Code(s): 0168-0016-31
- Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated July 27, 2012
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- Active Ingredient:
INDICATIONS & USAGE
- for temporary relief of itching associated with minor skin irritations and rashes due to:
- insect bites
- soaps and detergents
- seborrheic dermatitis
- poison ivy , oak or sumac
- for external genital, feminine and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
For external use only
Do not use
- in children under 2 years of age
- if you have a vaginal discharge
- for the treatment of diaper rash
Ask a doctor before use if you have
- external genital or feminine itching
- external anal itching
When using this product
- avoid contact with eyes
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor
- if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product
- Keep out of reach of children.
DOSAGE & ADMINISTRATION
For minor skin irritations and rashes,
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily .
For external anal itching:
- adults: 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 soft cloth before application of this product
- children: under 12 years of age, consult a doctor.
- SPL UNCLASSIFIED SECTION
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 5 mg in 1 g Inactive Ingredients Ingredient Name Strength petrolatum (UNII: 4T6H12BN9U) mineral oil (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0168-0016-31 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 01/01/1981 Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)