The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Anti Itch (NDC 59779-713). 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 PurposeCamphor 0.5%......................................external analgesicMenthol 0.5%....................................... external analgesic
Otc - Purpose
Uses for the temporary relief of pain and itching associated with minor skin irritations such aspoison ivy/oak/sumac, sunburn, insect bites and minor cuts and scrapes.
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 temporary relief of pain and itching associated with minor skin irritations such as
poison ivy/oak/sumac, sunburn, insect bites and minor cuts and scrapes.
Warnings
Warnings For external use onlyWhen using this product - avoid contact with the eyes.Stop use and ask a doctor if- condition worsens - symptoms persist for more than 7 days or clear up andoccur again within a few days.Keep out of reach of children. If swallowed, getmedical help or contact a Poison Control Center right away.
Dosage & Administration
Directions- Adults and children 2 years of age and older:- apply to the affected area not more than 3 to 4 times daily.Children under 2 years of age- consult a doctor.
Inactive Ingredient
Inactive Ingredientscarbomer 940, cetyl alcohol, DMDM hydantion, fragrance, glyceryl stearate,isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water,sodium hydroxide, stearic acid
* Please review the disclaimer below.