Label: HYDROCORTISONE WITH ALOE- hydrocortisone cream
- NDC Code(s): 63187-504-01
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 51672-2013
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 1, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
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
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE WITH ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-504(NDC:51672-2013) 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-504-01 1 in 1 CARTON 02/02/2015 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 08/23/1995 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-504)