Cerave Developed With Dermatologists Itch Relief Moisturizing Cream
FDA Label NDC 49967-512

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by L'oreal Usa Products Inc for the product Cerave Developed With Dermatologists Itch Relief Moisturizing (NDC 49967-512). 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 active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, do not use on, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Pramoxine hydrochloride 1%

Purpose

External analgesic

Use

For the temporary relief of itching associated with minor skin irritations.

Warnings

For external use only

When Using This Product

  • do not get into eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: consult a doctor.

Inactive Ingredients

water, glycerin, petrolatum, cetyl alcohol, stearic acid, butyrospermum parkii (shea) butter, cetearyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, dimethicone, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, phenoxyethanol, behentrimonium methosulphate, xanthan gum, sodium hydroxide, alcohol denat., ethylhexylglycerin, sodium lauroyl lactylate, disodium EDTA, potassium phosphate, dipotassium phosphate, tasmannia lanceolata fruit exact, phytosphingosine, cholesterol, carbomer

Questions Or Comments?

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