FDA.reportPublic FDA data

Cicatrix Skin Protectant

Manufacturer
Catalysis, SL
Effective date
2017-06-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:51:45

Label at a glance#

ProductCicatrix Skin Protectant
Active ingredientGLYCERIN
Label structure9 sections

Indications and uses

. helps to reduce the scars and marks in t he skin

Dosage and 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 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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Glycerin 3%.................... Skin Protectant

BottleBottle

Warnings

WARNINGS SECTION

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.

WARNINGS

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Questions or comments?

OTC - QUESTIONS SECTION

+ 34 M-F 9:00 am to 5:00 pm

Other Information

OTHER SAFETY INFORMATION

. keep the product in a cool and dry place

Directions

INSTRUCTIONS FOR USE SECTION

. 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 SECTION

  • 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

INDICATIONS & USAGE SECTION

. helps to reduce the scars and marks in t he skin

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Uses

OTC - PURPOSE SECTION

  • helps to reduce the scars and marks in t he skin

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CicatrixCicatrix

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-005-022020-01-31C16284748780-19d75b9d0-b7d9-f424-e053-dadaa90a57ceCicatrix

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-005-01Cicatrix Skin Protectant50 mL in 1 BOTTLE, PUMPCREAM502
64539-005-02Cicatrix Skin Protectant1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-005CICATRIX SKIN PROTECTANT (GLYCERIN) CREAM [CATALYSIS, SL]2Legacy NDC, 2 package rows20170629_4e8c0573-9db9-02f2-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64539-00564539-005-01, 64539-005-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
COUMARINA4VZ22K1WTIACT
HYALURONATE SODIUMYSE9PPT4THIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
PPG-11 STEARYL ETHERS4G2J0Y0LGIACT
STEARETH-2V56DFE46J5IACT
CERAMIDE 34370DF050BIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CERAMIDE 6 IIF1X8L2B00JIACT
CHOLESTEROL97C5T2UQ7JIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
WATER059QF0KO0RIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
XANTHAN GUMTTV12P4NEEIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
GLYCERINPDC6A3C0OXACTIB
STEARIC ACID4ELV7Z65APIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARETH-20L0Q8IK9E08IACT
SODIUM BENZOATEOJ245FE5EUIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
MALTODEXTRIN7CVR7L4A2DIACT
PALMITIC ACID2V16EO95H1IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
530b1834-7524-39c4-e054-00144ff8d46c4e8c0573-9db9-02f2-e054-00144ff88e882017-06-28WarningsExact identifier
spl id: 530b1834-7524-39c4-e054-00144ff8d46c
spl set id: 4e8c0573-9db9-02f2-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.