Label: HYDROCORTISONE ointment
- NDC Code(s): 63187-543-01
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 51672-2018
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 1, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
- •
- temporary relief of itching associated with minor skin irritations and rashes due to
- o
- eczema
- o
- insect bites
- o
- poison ivy, poison oak, or poison sumac
- o
- soaps
- o
- detergents
- o
- cosmetics
- o
- jewelry
- o
- seborrheic dermatitis
- o
- psoriasis
- o
- 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
Do not use
- •
- in the eyes
- •
- by putting this product into the rectum by using fingers or any mechanical device or applicator
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Directions
Adults and children 2 years of age 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 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 a soft cloth before application of this product
Children under 12 years of age: consult a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-543(NDC:51672-2018) 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 Medium-chain triglycerides (UNII: C9H2L21V7U) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-543-01 1 in 1 CARTON 12/01/2018 1 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 10/03/1989 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-543) , RELABEL(63187-543)