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

HC1% 1oz tube
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

HYDROCORTISONE
hydrocortisone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0316-0186
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ALCOHOL
STEARYL ALCOHOL
GLYCERIN
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
CETYL PALMITATE
SORBIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0316-0186-01 1 TUBE in 1 CARTON contains a TUBE
1 28.4 g in 1 TUBE This package is contained within the CARTON (0316-0186-01)
2 NDC:0316-0186-16 1 JAR in 1 CARTON contains a JAR
2 454 g in 1 JAR This package is contained within the CARTON (0316-0186-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080706 03/09/1973
HYDROCORTISONE
hydrocortisone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0316-0193
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ALCOHOL
STEARYL ALCOHOL
GLYCERIN
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
CETYL PALMITATE
SORBIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0316-0193-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (0316-0193-30)
2 NDC:0316-0193-20 1 TUBE in 1 CARTON contains a TUBE
2 20 g in 1 TUBE This package is contained within the CARTON (0316-0193-20)
3 NDC:0316-0193-16 1 JAR in 1 CARTON contains a JAR
3 454 g in 1 JAR This package is contained within the CARTON (0316-0193-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080706 01/06/2016
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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