Cvs Medicated Anti-itch
FDA Label NDC 59779-621

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 for the product Cvs Medicated Anti-itch (NDC 59779-621). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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                                 PurposeMenthol 1%....................................................Anti-Itch Pain ReliefPramoxine Hydrochloride 1%............................Anti-Itch Pain Relief

Otc - Purpose

UsesFor the temporary relief of pain and discomfort cause by- minor burns - sunburn - scrapes - insect bites- minor skin irritations - rashes due to poison ivy, oak and sumac

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

UsesFor the temporary relief of pain and discomfort cause by - minor burns - sunburn - scrapes - insect bites - minor skin irritations - rashes due to poison ivy, oak and sumac

Warnings

Warnings For external use onlyDo Not use - under bandages or compresses When using this product- avoid contact with the eyesStop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions- Adults and children 2 years and older: apply to affected area not more than 2 tim- Children under 2 years of age: do not use, consult a doctor

Inactive Ingredient

Inactive IngredientsWater, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Gel, Sodium Acrylates Copolymer, Mineral Oil, Steareth 21, PPG 1 Trideceth, 6, Toco[heryl Acetate, Disodium EDTA, Methyl Salicylate, Thymol, Eucalyptol, Triethanolamine, Iodopropynyl Butylcarbamate, Diozolidinyl Urea

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