The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Soothing Itch Relief (NDC 59779-051). 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 PurposeMenthol 0.1%..................................................External analgesic lotion
Otc - Purpose
Uses for the treatment 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
Uses for the treatment of itching associated with minor skin irritations.
Warnings
Warnings For external use onlyWhen using this product avoid contact with the eyesStop use and ask a doctor if- condition worsens - irritation occurs- symptoms persist for more than 7 days, or clear up and occur again within a few daysKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Dosage & Administration
DirectionsAdults and children 2 years of age and older,- apply to afected area not more than 3 to 4 times dailyChildren under 2 years of age,- consult a doctor
Inactive Ingredient
Inactive Ingredientsacrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, caprylic/capric triglyceride, cetearyl alcohol, cetyl alcohol, colloidal oatmeal, dimethicone, DMDM hydrantoin, glycerin, glyceryl stearate SE, isopropyl isostearate, myristyl, myristate, octyldodecanol, oenothera biennis oil (evening primrose), PEG-40 castor oil, phenoxyethanol, polyglyceryl-3 methylglucose distearate, potassium sorbate, purified water, sodium citrate
* Please review the disclaimer below.