Hydrocortisone Cream

Hydrocortisone Cream
SPL v1
SPL
SPL Set ID a584d3ad-9a00-4acc-bf73-6a3cd509b053
Route
TOPICAL
Published
Effective Date 2019-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Cetyl Alcohol Citric Acid Acetate Diazolidinyl Urea Edetate Disodium Glycerin Glyceryl Monostearate Methylparaben Mineral Oil Propylene Glycol Propylparaben Water Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1990-01-30

Description

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

How Supplied

Product: 50090-4456 NDC: 50090-4456-0 .9 g in a PACKET / 10 in a BOX, UNIT-DOSE


Medication Information

Warnings and Precautions

Warnings: For external use only. Do not get in eyes

Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately clal 911 or your local emergency provider.

Dosage and Administration

Directions:

Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

Children under 12 years of age: do not use, ask a doctor

How Supplied

Product: 50090-4456

NDC: 50090-4456-0 .9 g in a PACKET / 10 in a BOX, UNIT-DOSE

Description

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if:

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50570-1

Do not use:

  • in the eyes or over large portions of the body
  • for the treatment of diaper rash
  • with any other hydrocortisone product

Section 51727-6

Inactive Ingredients: Cetyl Alcohol, Citric Acid, Diazolidinyl Urea, Edetate Disodium, Glycerin, Glyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

Section 55105-1

Purpose: anti-itch cream

Section 55106-9

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

Hydrocortisone Acetate

Structured Label Content

Dosage and Administration (34068-7)

Directions:

Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

Children under 12 years of age: do not use, ask a doctor

Warnings and Precautions (34071-1)

Warnings: For external use only. Do not get in eyes

Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately clal 911 or your local emergency provider.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50570-1 (50570-1)

Do not use:

  • in the eyes or over large portions of the body
  • for the treatment of diaper rash
  • with any other hydrocortisone product

Section 51727-6 (51727-6)

Inactive Ingredients: Cetyl Alcohol, Citric Acid, Diazolidinyl Urea, Edetate Disodium, Glycerin, Glyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

Section 55105-1 (55105-1)

Purpose: anti-itch cream

Section 55106-9 (55106-9)

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

How Supplied (HOW SUPPLIED)

Product: 50090-4456

NDC: 50090-4456-0 .9 g in a PACKET / 10 in a BOX, UNIT-DOSE

Hydrocortisone Acetate (HYDROCORTISONE ACETATE)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)