Fifthpulse Hydrocortisone Ointment
FDA Label NDC 87525-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wecare Products Llc for the product Fifthpulse Hydrocortisone (NDC 87525-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop using this product and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
• eczema • insect bites • poison ivy • poison oak • poison sumac • soaps • detergents • cosmetics • jewelry • seborrheic dermatitis • psoriasis • external feminine, genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only.

Do Not Use

  • for the treatment of diaper rash, consult a doctor.
  • for external genital itching if you have vaginal discharge. consult a doctor.

When Using This Product

• avoid contact with eyes. • do not begin the use of any other hydrocortisone product unless you have consult a doctor. • for external genital, feminine and anal itching 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:

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Keep Out Of The Reach Of Children.

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

Directions

Adults and children 2 years and older

  • apply to affected area not more than 3 to 4 times daily.

    • Children under 2 years of age

    • do not use, consult a doctor.

      • For external and anal itching

      • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or blotting with tissue or a soft cloth before application of this product.
      • Children under 12 years of age with external anal itching:consult a doctor.

Other Information

  • Store at controlled room temperature 20° - 25° C (68° - 77° F)
  • Close cap tightly after use.

Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Edetate disodium, Methylparaben, Mineral oil, Mono-and di-glycerides, Petrolatum, Polysorbate 60, Propylene glycol, Propylparaben, Purified water, Sorbitan monostearate.

Questions Or Comments?

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