Medi-first Hydrocortisone Cream 1%

Medi-first Hydrocortisone Cream 1%
SPL v4
SPL
SPL Set ID f2b46d69-1c21-5ae9-e053-2a95a90a60a9
Route
TOPICAL
Published
Effective Date 2023-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • for the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration

Directions

  • for adults and children 2 years of age and older: apply to the affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • you begin use of any other Hydrocortisone product unless you have consulted a doctor
  • bleeding occurs
Section 50570-1

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
Section 51727-6

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glyceryl fatty acid ester, mineral oil,

petrolatum, phenoxyethanol, water

Section 51945-4

Medi-First®

1% Hydrocorisone Cream

Temporary relief of itching associated with minor skin irritation, inflamation and rashes

Item #21173

Net Wt. 0.9 g (1/32 oz) Packets/ 25 per box

Made in China

Section 53413-1

Questions or comments? 1-800-634-7680

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active ingredient

Hydrocortisone Acetate 1%

Section 60561-8

Other information

  • store at room temperature (do not freeze)
  • tamper evident. Do not use any opened or torn packets

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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration (34068-7)

Directions

  • for adults and children 2 years of age and older: apply to the affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • you begin use of any other Hydrocortisone product unless you have consulted a doctor
  • bleeding occurs
Section 50570-1 (50570-1)

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
Section 51727-6 (51727-6)

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glyceryl fatty acid ester, mineral oil,

petrolatum, phenoxyethanol, water

Section 51945-4 (51945-4)

Medi-First®

1% Hydrocorisone Cream

Temporary relief of itching associated with minor skin irritation, inflamation and rashes

Item #21173

Net Wt. 0.9 g (1/32 oz) Packets/ 25 per box

Made in China

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active ingredient

Hydrocortisone Acetate 1%

Section 60561-8 (60561-8)

Other information

  • store at room temperature (do not freeze)
  • tamper evident. Do not use any opened or torn packets

Advanced Ingredient Data


Raw Label Data

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