Label: HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream
- NDC Code(s): 68016-909-01
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 6, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
-
Use
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
- eczema
- psoriasis
- insect bites
- poison ivy, oak, sumac
- detergent
- jewelry
- cosmetics
- soaps seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should be only under the advise and supervision of a doctor
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
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Warnings
For external use only
Do not use
- in the genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult
When using this product
- avoid contact with the eyes
- do not use more than directed unless directed by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
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Direction
- for itching of skin irritation, inflammation, and rashes
- 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: consult a doctor
- for external anal and genital itching
- adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- apply to affected area not more than 3 to4 times daily
- children under 12 years of age: consult a doctor
- for itching of skin irritation, inflammation, and rashes
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
COMPARE TO THE ACTIVE INGREDIENT IN MAXIMUM STRENGTH CORTIZONE 10®†
MAXIMUM STRENGTH
Hydrocortisone Cream USP, 1%
ANTI-ITCH CREAM
Relieves
Itches and Rashes
NET WT. OZ (g)
For the temporary relief of itching associated with minor skin irritations, inflammation and rashes
†This product is not manufactured or distributed by Chattem, Inc., distributor of Maximum Strength Cortizone 10®.
Distributed by:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
- Package label
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-909 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 CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBIC ACID (UNII: X045WJ989B) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WHITE WAX (UNII: 7G1J5DA97F) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-909-01 1 in 1 CARTON 05/07/2021 1 28 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 05/07/2021 Labeler - Chain Drug Consortium, LLC (101668460)