globe hydrocortisone cream 1%

globe hydrocortisone cream 1%
SPL v5
SPL
SPL Set ID f4d4a56b-b4b7-9a07-e053-2a95a90ad853
Route
topical
Published
Effective Date 2026-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
phenoxyethanol mineral oil glycerin glyceryl monostearate petrolatum water polyoxyl 20 cetostearyl ether cetostearyl alcohol ethylhexylglycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-05-31

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone 1%


Medication Information

Warnings

For external use only

Uses

For temporary relief of itching associated with minor skin irritations and rashes

● external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Purpose

Antipruritic (Anti-Itch)

Directions

Adults and children 2 years of age and older: apply to the 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 and anal 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

For External anal and genital itching in children under 12 years of age:

Ask a doctor

Other Information

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Tamper evident, do not use if packet is torn, cut or opened.

Avoid excessive heat and humidity.

Inactive Ingredients

Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.

Description

Hydrocortisone 1%

Label

Section 42229-5

Distributed by:

Trifecta Pharmaceuticals USA™

Ft. Lauderdale, FL 33301 USA

Online: www.trifecta-pharma.com

Reorder No. 1016SL

To reorder call: 1-888-296-9067

Fax: 888-878-3609

Section 50565-1

Keep out of the reach of children.

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

Packaging

Questions

Call 1-888-296-9067

Drug Facts

Do Not Use
  • For the treatment of diaper rash, consult a doctor.
  • With any other Hydrocortisone product unless you have consulted a doctor
  • If you have a vaginal discharge, consult a doctor

Active Ingredient

Hydrocortisone 1%

When Using This Product
  • Avoid Contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Using This Product and Ask A Doctor If
  • conditions 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

Structured Label Content

Warnings

For external use only

Uses

For temporary relief of itching associated with minor skin irritations and rashes

● external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Purpose

Antipruritic (Anti-Itch)

Directions

Adults and children 2 years of age and older: apply to the 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 and anal 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

For External anal and genital itching in children under 12 years of age:

Ask a doctor

Other Information (Other information)

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Tamper evident, do not use if packet is torn, cut or opened.

Avoid excessive heat and humidity.

Inactive Ingredients (Inactive ingredients)

Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.

Label (LABEL)

Section 42229-5 (42229-5)

Distributed by:

Trifecta Pharmaceuticals USA™

Ft. Lauderdale, FL 33301 USA

Online: www.trifecta-pharma.com

Reorder No. 1016SL

To reorder call: 1-888-296-9067

Fax: 888-878-3609

Section 50565-1 (50565-1)

Keep out of the reach of children.

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

Packaging

Questions

Call 1-888-296-9067

Drug Facts (DRUG FACTS)

Do Not Use
  • For the treatment of diaper rash, consult a doctor.
  • 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%

When Using This Product (When using this product)
  • Avoid Contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)
  • conditions 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

Advanced Ingredient Data


Raw Label Data

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