Active Ingredients Purpose
Glycerin 3%.................... Skin Protectant
Bottle (Cremapequena)
Cicatrix Skin Protectant
FDA Label NDC 64539-005
9 label sections · Submitted to the FDA by Catalysis, Sl · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Catalysis, Sl for the product Cicatrix Skin Protectant (NDC 64539-005). 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 ingredients purpose, warnings, questions or comments?, other information, directions, dosage & administration, uses, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For external use only.
Do not use on damaged or broken skin.
When using this product keep our of the eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children
Children under 6 months: as a doctor.
Stop use and ask a doctor if rash occurs
Children under 6 months: ask a doctor
Keep out of reach of children
Questions Or Comments?
+ 34 M-F 9:00 am to 5:00 pm
Other Information
. keep the product in a cool and dry place
Directions
. clean and dry the affected area.
. apply the product and massage the affected area
. follow the instructions on the insert
. apply at least twice a day
Dosage & Administration
- clean and dry the affected area.
- apply the product and massage the affected area
- follow the instructions on the insert
- apply at least twice a day
Uses
. helps to reduce the scars and marks in t he skin
- helps to reduce the scars and marks in t he skin
Inactive Ingredients
Aqua, Cyclopentasiloxane, Cetearyl Alcohol, PPG-11 Stearyl Ether, Steareth-2, Ceramide 3, Ceramide 6II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Centella Asiatica Leaf Extract, Maltodextrin, Stearic Acid, Palmitic Acid, Phenoxyethanol, Ethylhexylglycerin, C12-C15 Alkyl Benzoate, Steareth-20, Pinus Sylvestris Bud Extract, Sodium Benzoate, Potassium Sorbate, Sodium Hyaluronate, Carbomer, Diazolydinil Urea, Parfum( coumarin, hexyl cinnamal,linalool,d-limonene/dipentene/l-limonene,Geraniol,hydroxycitronellal), Sodium Hydroxide
Package Label
Cicatrix (Cicatrix)
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