Cvs Health Maximum Strength Hydrocortisone Ointment
FDA Label NDC 51316-165

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Health for the product Cvs Health Maximum Strength Hydrocortisone (NDC 51316-165). 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 use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch 

Uses

■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics

■ soaps ■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

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

Warnings

For external use only 

Do Not Use

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

When Using This Product

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily
  • children under 2 years of age: ask a doctor
  • for external anal itching,

    • adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily

      • children under 12 years of age: ask a doctor

Other Information

  • Store at a controlled room temperature 20-25°C ( 68-77°F)
  • before using any medication read all label direction, keep carton it contains important information 

Inactive Ingredient

Petrolatum 

Principal Display Panel

CVS              NDC 51316-165-28    

Maximum strength

Cortisone Ointment 

Hydrocortisone 1%

NET WT 1.0 OZ  (28g)

503200-cvshealth-max-strength-cortisone-ointment-1-oz-carton (503200 Cvshealth Max Strength Cortisone Ointment 1 Oz Carton)

503200-cvshealth-max-strength-cortisone-ointment-1-oz-carton (503200 Cvshealth Max Strength Cortisone Ointment 1 Oz Carton)

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