Medi-first

Medi-first
SPL v1
SPL
SPL Set ID f4e64bc7-f316-a03d-e053-2a95a90a76a1
Route
TOPICAL
Published
Effective Date 2023-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Petrolatum Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl 1-stearate Ethylhexylglycerin Phenoxyethanol Glycerin Mineral Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-02-17

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses
  • for the temporary relief of itching associated with minor skin irritation,inflammation and rashed due to eczema, insect bites, poison ivy, poison oak,poison sumac, soaps, detergents, cosmetics,jewelry, sebortheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

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

(continued on side panel)

  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Do Not Use
  • for treatment of diaper rash
  • in eyes
  • for feminine itching
Drug Facts

Active Ingredient

Hydrocortisone 1%

Other Information
  • store at room temperature (do not freeze)
  • tamper evident, do not use any opened or torn packets
Package Labeling:

Inactive Ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolatum, phenoxyethanol, water

Questions Or Comments?

1-800-634-7680

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
  • bleeding occurs
Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • for the temporary relief of itching associated with minor skin irritation,inflammation and rashed due to eczema, insect bites, poison ivy, poison oak,poison sumac, soaps, detergents, cosmetics,jewelry, sebortheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor

Purpose

Anti-itch

Warnings

For external use only

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

(continued on side panel)

  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Do Not Use (Do not use)
  • for treatment of diaper rash
  • in eyes
  • for feminine itching
Drug Facts

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • store at room temperature (do not freeze)
  • tamper evident, do not use any opened or torn packets
Package Labeling:

Inactive Ingredients (Inactive ingredients)

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolatum, phenoxyethanol, water

Questions Or Comments? (Questions or comments?)

1-800-634-7680

Stop Use and Ask A Doctor If (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
  • 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.


Advanced Ingredient Data


Raw Label Data

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