DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Hydrocortisone (1 g)

Inactive Ingredients

Microcrystalline Wax Phenoxyethanol Tocopherol Cocos Nucifera (coconut) Oil Butyrospermum Parkii (shea) Butter

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-21

Medication Information

Warnings and Precautions

For external use only. Avoid contact with eyes.

Indications and Usage

USES

For the temporary relief of itching

associated with minor skin

irritations and rashes due to:

Eczema
Cosmetics
Psoriasis
Seborrheic Dermatitis
Other uses of this product should

be only under the advice and

supervision of a physician.

Dosage and Administration

D IRECTIONS

Adults and children 2 years of

age and older: apply to affected

area not more than 3 to 4 times

daily for up to 7 days.

Children under 2 years of age:

do not use, consult a physician

Description

ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch

Section 43683-2

Removed "Warnings and Precautions section"
Added "OTC - Purpose section" - "ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch"
Added "Warnings section" - "For external use only. Avoid contact with eyes."
Added "OTC - Stop use section" - "and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor."
Added "OTC - Do not use section" - "for the treatment of diaper rash. Consult a doctor."
Added "OTC - Keep out of reach of Children section"

Section 44425-7

OTHER INFORMATION

Store at 59-80 F (15-30 C).

Protect from freezing.

Section 50565-1

Keep out of reach of children

Section 50566-9

and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor.

Section 50570-1

for the treatment of diaper rash. Consult a doctor.

Section 51727-6

INACTIVE INGREDIENTS

coconut oil, shea butter, cera

microcristallina, tocopherol,

phenoxyethanol

Section 51945-4

Section 55105-1

ACTIVE INGREDIENT PURPOSE

Hydrocortisone 1.0%...........Anti-Itch

Section 55106-9

ACTIVE INGREDIENT PURPOSE

Hydrocortisone 1.0%...........Anti-Itch

Structured Label Content

Indications and Usage (34067-9)

USES

For the temporary relief of itching

associated with minor skin

irritations and rashes due to:

Eczema
Cosmetics
Psoriasis
Seborrheic Dermatitis
Other uses of this product should

be only under the advice and

supervision of a physician.

Dosage and Administration (34068-7)

D IRECTIONS

Adults and children 2 years of

age and older: apply to affected

area not more than 3 to 4 times

daily for up to 7 days.

Children under 2 years of age:

do not use, consult a physician

Warnings and Precautions (34071-1)

For external use only. Avoid contact with eyes.

Section 43683-2 (43683-2)

Removed "Warnings and Precautions section"
Added "OTC - Purpose section" - "ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch"
Added "Warnings section" - "For external use only. Avoid contact with eyes."
Added "OTC - Stop use section" - "and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor."
Added "OTC - Do not use section" - "for the treatment of diaper rash. Consult a doctor."
Added "OTC - Keep out of reach of Children section"

Section 44425-7 (44425-7)

OTHER INFORMATION

Store at 59-80 F (15-30 C).

Protect from freezing.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor.

Section 50570-1 (50570-1)

for the treatment of diaper rash. Consult a doctor.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

coconut oil, shea butter, cera

microcristallina, tocopherol,

phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

ACTIVE INGREDIENT PURPOSE

Hydrocortisone 1.0%...........Anti-Itch

Section 55106-9 (55106-9)

ACTIVE INGREDIENT PURPOSE

Hydrocortisone 1.0%...........Anti-Itch

Advanced Ingredient Data

[{"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCORTISONE", "unii": "WI4X0X7BPJ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCOS NUCIFERA (COCONUT) OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYROSPERMUM PARKII (SHEA) BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "USES For the temporary relief of itching associated with minor skin irritations and rashes due to: Eczema Cosmetics Psoriasis Seborrheic Dermatitis Other uses of this product should be only under the advice and supervision of a physician.", "34068-7": "D IRECTIONS Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily for up to 7 days. Children under 2 years of age: do not use, consult a physician", "34071-1": "For external use only. Avoid contact with eyes.", "43683-2": "Removed "Warnings and Precautions section" Added "OTC - Purpose section" - "ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch" Added "Warnings section" - "For external use only. Avoid contact with eyes." Added "OTC - Stop use section" - "and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor." Added "OTC - Do not use section" - "for the treatment of diaper rash. Consult a doctor." Added "OTC - Keep out of reach of Children section"", "44425-7": "OTHER INFORMATION Store at 59-80 F (15-30 C). Protect from freezing.", "50565-1": "Keep out of reach of children", "50566-9": "and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor.", "50570-1": "for the treatment of diaper rash. Consult a doctor.", "51727-6": "INACTIVE INGREDIENTS coconut oil, shea butter, cera microcristallina, tocopherol, phenoxyethanol", "55105-1": "ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch", "55106-9": "ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information