Hydrocortisone (Page 2 of 2)
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systems effects (See PRECAUTIONS).
DOSAGE AND 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.
PACKAGING AND STORAGE
Store at 20 o — 25 o C (68 o — 77 o F) [see USP Controlled Room Temperature].
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
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
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
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
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Labeler — Crown Laboratories (079035945) |
Registrant — Crown Laboratories (079035945) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Crown Laboratories | 079035945 | manufacture (0316-0186), manufacture (0316-0193) |
Revised: 10/2023 Crown Laboratories
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