The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Fragrance Free Anti-itch (NDC 59779-052). 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.
Otc - Active Ingredient
Active ingredient PurposePramoxine Hydrochloride...................................External Analgesic
Otc - Purpose
UsesFor the temporary relief of itching associated with minor skin irritations
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 itching associated with minor skin irritations
Warnings
Warnings For external use onlyWhen using this product- avoid contact with eyesStop 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.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 3 to 4 times dailychildren under 2 years of age- consult a doctor
Inactive Ingredient
Inactive Ingredientswater, isopropyl myristate, stearic acid, glyceryl stearate, PEG-100 stearate, cetyl alcohol, PEG-8, petrolatum, dimethicone, benzyl alcohol, carbomer, sodium hydroxide
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