Cvs Fragrance Free Anti-itch
FDA Label NDC 11822-0405

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Cvs Fragrance Free Anti-itch (NDC 11822-0405). 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                                 PurposePramoxine Hydrochloride 1%............................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 Ingredientsbenzyl alcohol, carbomer, cetyl alcohol, dimethicone, glycerul stearate, isopropyl myristate,PEG-8, PEG-100 stearate, petrolatum, purified water, sodium hydroxide, stearic acid

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