Cvs Health Maximum Strength Hydrocortisone Ointment
FDA Label NDC 51316-165
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.
Label Section Quick Index
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
- 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
- children under 12 years of age: ask a doctor
for external anal itching,
apply to affected area not more than 3 to 4 times daily
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
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