Medi-first 1% Hydrocortisone Cream

Medi-first 1% Hydrocortisone Cream
SPL v6
SPL
SPL Set ID 8ed6b334-5e1d-1c53-e053-2a95a90aaa49
Route
TOPICAL
Published
Effective Date 2020-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Methylparaben Phenoxyethanol Polysorbate 80 Titanium Dioxide Trisodium Citrate Dihydrate Benzoic Acid Citric Acid Monohydrate Petrolatum Water Mineral Oil Glyceryl Monostearate Chlorphenesin Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Completed Since 2020-01-01 Until 2024-12-01

Description

Hydrocortisone 1.0%

Purpose

Antipruritic (ant-itch)


Medication Information

Purpose

Antipruritic (ant-itch)

Description

Hydrocortisone 1.0%

Uses
  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
  • for external genital, feminine, and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Warnings

For external use only.

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 and ask a doctor

For external anal and genital itching in adults:

  • when practical, clean affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying

Children under 12 years of age: ask a doctor

Do Not Use
  • for the treatment of diaper rash
  • with any other Hydrocortisone product unless you have consulted a doctor
  • if you have a vaginal discharge, consult a doctor
Active Ingredient

Hydrocortisone 1.0%

Other Information
  • store at room temperature 59° to 86° F (15° to 30° C)
  • tamper evident, do not use if packet is torn, cut or opened
  • avoid excessive heat and humidity
Inactive Ingredients

benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate

Questions Or Comments?

1-800-634-7680

When Using This Product
  • avoid contact with eyes
  • do not put this product into rectum by using fingers, mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor
Stop Use and Ask A Doctor If
  • condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
  • rectal bleeding occurs
Keep Out of Reach of Children.

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

Medi First 1% Hydrocortisone Cream Label

Medi-First®

1% Hydrocortisone Cream

Temporary relief of itching associated with minor skin irritation and rashes

Item # 21173

0.9g (1/32oz) Packets

25 per box

Medi First Plus 1% Hydrocortisone Cream Label

Medi-First® Plus

Hydrocortisone Cream 1%

Temporary relief of itching associated with minor skin irritation and rashes

25 Units of 0.9g (1/32oz) Packets

Item # 93373


Structured Label Content

Uses
  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
  • for external genital, feminine, and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Antipruritic (ant-itch)

Warnings

For external use only.

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 and ask a doctor

For external anal and genital itching in adults:

  • when practical, clean affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying

Children under 12 years of age: ask a doctor

Do Not Use (Do not use)
  • for the treatment of diaper rash
  • with any other Hydrocortisone product unless you have consulted a doctor
  • if you have a vaginal discharge, consult a doctor
Active Ingredient (Active ingredient)

Hydrocortisone 1.0%

Other Information (Other information)
  • store at room temperature 59° to 86° F (15° to 30° C)
  • tamper evident, do not use if packet is torn, cut or opened
  • avoid excessive heat and humidity
Inactive Ingredients (Inactive ingredients)

benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate

Questions Or Comments? (Questions or comments?)

1-800-634-7680

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not put this product into rectum by using fingers, mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
  • rectal bleeding occurs
Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

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

Medi First 1% Hydrocortisone Cream Label (Medi-First 1% Hydrocortisone Cream Label)

Medi-First®

1% Hydrocortisone Cream

Temporary relief of itching associated with minor skin irritation and rashes

Item # 21173

0.9g (1/32oz) Packets

25 per box

Medi First Plus 1% Hydrocortisone Cream Label (Medi-First Plus 1% Hydrocortisone Cream Label)

Medi-First® Plus

Hydrocortisone Cream 1%

Temporary relief of itching associated with minor skin irritation and rashes

25 Units of 0.9g (1/32oz) Packets

Item # 93373


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