Cvs Pharmacy Anti-itch
FDA Label NDC 59779-307

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 for the product Cvs Pharmacy Anti-itch (NDC 59779-307). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                               Purpose

Hydrocortisone 1%.............................................................Anti-itch

Otc - Purpose

Uses

  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use for the treatment of diaper rash. Consult a doctor.

Otc - When Using

When using this product

  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not being use of any other hydrocortisone product unless you have consulted a doctor.

Otc - 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.

Indications & Usage

Directions

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 12 of age: do not use, consult a doctor

Inactive Ingredient

Inactive ingredients aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

Dosage & Administration

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Made in Korea

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