FDA.reportPublic FDA data

Scarzen

Manufacturer
Village Pharma LLC | Pure Source, LLC
Effective date
2026-01-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:33:45

Label at a glance#

ProductScarzen
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure6 sections

Indications and uses

Temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

Cleanse the affected area and allow to dry. Apply as needed.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5.00%

OTC - PURPOSE SECTION

Skin Protectant

USES:

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve chapped or cracked skin

WARNINGS:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.

Stop use and ask a doctor 

OTC - STOP USE SECTION

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

Do not use

OTC - DO NOT USE SECTION

on deep or puncture wounds, animal bites or serious burns.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS (Adults and Children Over 12 Years):

DOSAGE & ADMINISTRATION SECTION

Cleanse the affected area and allow to dry. Apply as needed.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Aloe Barbadensis (Aloe Vera Gel) Juice, Glyceryl Stearate, PEG-100 Stearate, Carthamus Tinctorius (Sunflower) Oil, Stearic Acid, Cetyl Alcohol, Butylene Glycol, Glycerin, Sodium Ascorbyl Phosphate (Vitamin C), Tocopheryl Acetate (Vitamin E), Hyaluronic Acid, Zingiber Officinale (Ginger) Extract, Pyridoxine HCL (Vitamin B6), Pantothenic Acid (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Disodium EDTA, Silica, Triethanolamine, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1602161dimethicone 5 % Topical LotionPSN5
1602161dimethicone 50 MG/ML Topical LotionSCD5
1602161dimethicone 5 % Topical LotionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371574500723GTIN-13: 0371574500723
EAN-13: 0371574500723
GTIN-12: 371574500723
UPC-A: 371574500723
GTIN storage (14 digits): 00371574500723		Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71574-500-722021-10-22C16284748780-1ba0f9c33-37f8-a910-e053-dadaa90a0b85Scarzen (Dimethicone 5%)
71574-500-722021-01-29C16284748780-1ba0f9c33-37f8-a910-e053-dadaa90a0b85Scarzen (Dimethicone 5%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71574-500-72Scarzen1 in 1 BOXLOTION15
71574-500-72Scarzen120 mL in 1 BOTTLELOTION1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-500-72ML - Milliliter71574-500bd03d91c-89a9-4404-8928-668e1cea1ad412018-11-06

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71574-50071574-500-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
HYALURONIC ACIDS270N0TRQYIACT
GINGERC5529G5JPQIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
PANTOTHENIC ACID19F5HK2737IACT
SAFFLOWER4VBL71TY4YIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TROLAMINE9O3K93S3TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ScarzenDIMETHICONEVillage Pharma LLC1550f4e5-22e2-491f-8184-de65da7234e62026-01-01WarningsExact identifier
ndc (package): 71574-500-72
ndc (product): 71574-500
ndc11 (package): 71574050072
spl id: 5672d48b-d218-46bd-8d40-c77bb6abf1ef
spl set id: 1550f4e5-22e2-491f-8184-de65da7234e6
ScarzenTRIAMCINOLONE ACETONIDE, DIMETHICONEVillage Pharma LLC4777b129-5f7e-49af-9cf7-65158fdf43482024-11-01Warnings, Adverse reactionsExact identifier
ndc (package): 71574-500-72
ndc11 (package): 71574050072

Reported adverse events (FAERS/openFDA)#

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