Advanced Anti-itch Therapy
FDA Label NDC 69842-345

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 Pharmacy, Inc. for the product Advanced Anti-itch Therapy (NDC 69842-345). 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 active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, 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

Use

■ for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
■ eczema ■ poison ivy, oak, sumac ■ insect bites ■ detergents
■ jewelry ■ soaps ■ external 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

Otc - Keep Out Of Reach Of Children

  • 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 of age and older:
■wash affected area not more than 3 to 4 times daily children under 2 years of age:
■do not use. Ask a doctor.

When Using This Product

When using this product ■ avoid contact with the eyes.

Stop Use And Ask A Doctor If

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

Do Not Use

Do not use ■ for external genital itching if you have a vaginal discharge. Ask a doctor

Label

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