324dd151-84c5-3e2f-e063-6394a90a569d

SPL v3
SPL
SPL Set ID 324dd151-84c5-3e2f-e063-6394a90a569d
Route
topical
Published
Effective Date 2025-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Description

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


Medication Information

Warnings and Precautions

For external use only. Avoid contact with eyes.

Active Ingredient

ACTIVE INGREDIENT PURPOSE

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

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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only. Avoid contact with eyes.

Active Ingredient (55106-9)

ACTIVE INGREDIENT PURPOSE

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

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)