Label: HYDROCORTISONE CREAM 1% WITH ALOE VERA- hydrocortisone cream
- NDC Code(s): 79503-202-30
- Packager: Ezricare Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 11, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
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Uses
• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:• eczema • seborrheic dermatitis • psoriasis • Insect bites • poison ivy, poison oak, and poison sumac • cosmetics • jewelry • detergents • soaps • temporarily relieves external anal and genital 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 • for the treatment of diaper rash. Ask a doctor. • for external genital itching if you have a vaginal discharge. Ask a doctor. • for external anal itching if rectal bleeding occurs. Consult a doctor promptly.
When using this product • do not get into the eyes • for external anal itching, do not use more than directed, unless told so by a doctor. • do not put into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.
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Directions
• adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily. • children under 2 years: ask a doctor • For external anal itching in adults: • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad • gently dry by patting or blotting with toilet tissue or soft cloth before applying • for external anal itching in children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE CREAM 1% WITH ALOE VERA
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79503-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) WHITE PETROLATUM (UNII: B6E5W8RQJ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79503-202-30 1 in 1 CARTON 06/01/2021 07/01/2025 1 30 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 06/01/2021 07/01/2025 Labeler - Ezricare Llc (117573818)