Active Ingredient
Pramoxine hydrochloride 1%
Cerave Developed With Dermatologists Itch Relief Moisturizing Lotion
FDA Label NDC 49967-970
12 label sections · Submitted to the FDA by L'oreal Usa Products Inc · 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 49967-970). 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
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, isopropyl myristate, PEG-100 stearate, glyceryl stearate, cetearyl alcohol, cetyl alcohol, glycerin, niacinamide, dimethicone, stearic acid, allantoin, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, zinc citrate, behentrimonium methosulfate, sodium hydroxide, sodium lauroyl lactylate, arginine PCA, myristic acid, sodium PCA, cholesterol, palmitic acid, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., tocopheryl acetate, hydrolyzed hyaluronic acid, xanthan gum, phytosphingosine, polyglyceryl-3 diisostearate, ethylhexylglycerin
Questions?
Toll-Free Number 888-768-2915
www.cerave.com
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