43473-049-01_hydrocortisone

43473-049-01_hydrocortisone
SPL v3
SPL
SPL Set ID fbbbcc67-b46d-d41a-e053-6294a90aa55d
Route
TOPICAL
Published
Effective Date 2024-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Ethylhexylglycerin Glycerin Mineral Oil Petrolatum Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-08

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses
  • for the temporary relief of itching associated with minor irritations and rashes
  • other uses of this product should be only under the advice and superivision of a doctor.
Warnings

For external use only.

Avoid contact with the eyes.

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use.
Do Not Use

for the treatment of diaper rash. Consult a doctor.

Drug Facts

Active Ingredient

Hydrocortisone 1%

Package Labeling:

Inactive Ingredients

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Do Not Use, Consult A Doctor

if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not use if the packaging is broken

Keep Out of Reach of Children.

If swallowed contact a Poison Control Center right away.


Structured Label Content

Uses
  • for the temporary relief of itching associated with minor irritations and rashes
  • other uses of this product should be only under the advice and superivision of a doctor.
Purpose

Anti-itch

Warnings

For external use only.

Avoid contact with the eyes.

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use.
Do Not Use (Do not use)

for the treatment of diaper rash. Consult a doctor.

Drug Facts

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Do Not Use, Consult A Doctor (Do not use, consult a doctor)

if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not use if the packaging is broken

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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