Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Cream USP, 1% is supplied in: 1 ounce (28.4 grams) tube NDC 0316-0186-01 454 grams jar NDC 0316-0186-16 Hydrocortisone Cream USP, 2.5% is supplied in: 20 grams tube NDC 0316-0193-20 30 grams tube NDC 0316-0193-30 454 grams jar NDC 0316-0193-16 Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, Tennessee 37604 PRINTED IN USA Revised Dec 2017 P6306.03; Hydrocortisone Cream USP, 1% - 1oz Label NDC 0316-0186-01 Rx Only Hydrocortisone Cream USP, 1% Warning: Keep out of reach of children. For external use only. Not for ophthalmic use. 1oz (28.4 grams) Each gram contains: 10 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. TO OPEN: Use cap to pucture seal. IMPORTANT: Do not use if seal has been puctured or is not visible. Store at 20 o -25 o C (68 o -77 o F)[see USP Controlled Room Temperature]. See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P6300.01 HC1% 1oz tube; Hydrocortisone Cream USP, 1% -1oz Carton NDC 0316-0186-01 Rx Only Hydrocortisone Cream USP, 1% Warning: Keep out of reach of children. For external use only. Not for ophthalmic use. 1oz (28.4 grams) Each gram contains: 10 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to reseal tube. Store at 20 o -25 o C (68 o -77 o F)[see USP Controlled Room Temperature]. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. See end of carton for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P6304.02 HC1%-1oz-carton; Hydrocortisone Cream USP, 2.5% 30 grams Label NDC 0316-0193-30 Rx Only Hydrocortisone Cream USP, 2.5% 30 grams WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. Each gram contains: 25 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. TO OPEN: Use cap to puncture seal. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20°C-25°C (68°-77°F) [see USP Controlled Room Temperature]. See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P11337.00 HC 2.5% 30g tube; Hydrocortisone Cream USP, 2.5% 30 grams Carton NDC 0316-0193-30 Rx Only Hydrocortisone Cream USP, 2.5% WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 30 grams Each gram contains: 25 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to reseal tube. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. See end of carton for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P11338.00 HC 2.5% 30g carton
- HOW SUPPLIED Hydrocortisone Cream USP, 1% is supplied in: 1 ounce (28.4 grams) tube NDC 0316-0186-01 454 grams jar NDC 0316-0186-16 Hydrocortisone Cream USP, 2.5% is supplied in: 20 grams tube NDC 0316-0193-20 30 grams tube NDC 0316-0193-30 454 grams jar NDC 0316-0193-16 Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, Tennessee 37604 PRINTED IN USA Revised Dec 2017 P6306.03
- Hydrocortisone Cream USP, 1% - 1oz Label NDC 0316-0186-01 Rx Only Hydrocortisone Cream USP, 1% Warning: Keep out of reach of children. For external use only. Not for ophthalmic use. 1oz (28.4 grams) Each gram contains: 10 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. TO OPEN: Use cap to pucture seal. IMPORTANT: Do not use if seal has been puctured or is not visible. Store at 20 o -25 o C (68 o -77 o F)[see USP Controlled Room Temperature]. See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P6300.01 HC1% 1oz tube
- Hydrocortisone Cream USP, 1% -1oz Carton NDC 0316-0186-01 Rx Only Hydrocortisone Cream USP, 1% Warning: Keep out of reach of children. For external use only. Not for ophthalmic use. 1oz (28.4 grams) Each gram contains: 10 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to reseal tube. Store at 20 o -25 o C (68 o -77 o F)[see USP Controlled Room Temperature]. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. See end of carton for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P6304.02 HC1%-1oz-carton
- Hydrocortisone Cream USP, 2.5% 30 grams Label NDC 0316-0193-30 Rx Only Hydrocortisone Cream USP, 2.5% 30 grams WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. Each gram contains: 25 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. TO OPEN: Use cap to puncture seal. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20°C-25°C (68°-77°F) [see USP Controlled Room Temperature]. See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P11337.00 HC 2.5% 30g tube
- Hydrocortisone Cream USP, 2.5% 30 grams Carton NDC 0316-0193-30 Rx Only Hydrocortisone Cream USP, 2.5% WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 30 grams Each gram contains: 25 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to reseal tube. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. See end of carton for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P11338.00 HC 2.5% 30g carton
Overview
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C 21 H 30 O 5 and molecular weight is 362.47. Its structural formula is: Each gram of Hydrocortisone Cream USP, 1% contains 10 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. hcstructure
Indications & Usage
Topcial corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Warnings & Precautions
No warnings available yet.
Contraindications
Topcial corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/
Storage & Handling
PACKAGING AND STORAGE Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].
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