Itch Relief Clear Skin Protectant
FDA Label NDC 59779-295

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 Itch Relief Clear Skin Protectant (NDC 59779-295). 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, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Pramoxine  HCl 1%

Zinc Acetate 0.1%

Purpose

Itch Relief.

Uses

  • Temporarily relieves pain and itching asociated with:
  • rashes due to poison ivy, poison oak or poison sumac.
  • insect bites.
  • minor skin irritation.
  • minor cuts.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

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When Using This Product

  • keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120F.

Stop Use And Ask A Doctor If

  • condition worsens or does not improve within 7 days.
    • symptoms persist for more than 7 days or clear up and occur again with in a few days.

Keep Out Of Reach Of Children

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

Directions

  • shake well before use.
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: ask a doctor. 

Inactive Ingredients

SD Alcohol 38-B, Avena Sative (Oat Meal) Extract, Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin, Hypromellose, Methylparaben,Polysorbate 40, Propylene Glycol, Propylparaben, Sodium Citrate, Water.

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