Medi-first 1% Hydrocortisone

Medi-first 1% Hydrocortisone
SPL v18
SPL
SPL Set ID e90df2e5-2ef4-47dd-bd74-be9cea6d9d85
Route
TOPICAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Alcohol Methylparaben Mineral Oil Paraffin Petrolatum Propylparaben Water White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-15

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, inflamation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, 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 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 an appropriate cleansing pad
  • gently dry by patting or botting 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 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
  • with anyother Hydrocortisone product unless you have consulted adoctor
  • if you have vaginal discharge, consulkt a doctor
Section 51727-6

Inactive ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Section 51945-4

Medi First® Plus

Hydrocortisone Cream 1%

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

25 units / Net Wt 0.9 g (1/32 oz)

Item #93373

Section 53413-1

Questions or Comments? 1-800-634-7680

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active ingredient

Hydrocortisone 1.0%

Medi First Hydrocortisone Label

MEDI-FIRST®

1% Hydrocortisone Cream

Temporary relief of itching associated with

minor skin irritation, inflammation and rashes

Product # 24369

10 units of 0.9gm (1/32oz) Packets


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of itching associated with minor skin irritations, inflamation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, 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 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 an appropriate cleansing pad
  • gently dry by patting or botting 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 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
  • with anyother Hydrocortisone product unless you have consulted adoctor
  • if you have vaginal discharge, consulkt a doctor
Section 51727-6 (51727-6)

Inactive ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Section 51945-4 (51945-4)

Medi First® Plus

Hydrocortisone Cream 1%

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

25 units / Net Wt 0.9 g (1/32 oz)

Item #93373

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 1.0%

Medi First Hydrocortisone Label (Medi-First Hydrocortisone Label)

MEDI-FIRST®

1% Hydrocortisone Cream

Temporary relief of itching associated with

minor skin irritation, inflammation and rashes

Product # 24369

10 units of 0.9gm (1/32oz) Packets


Advanced Ingredient Data


Raw Label Data

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