FDA.reportPublic FDA data

Glizigen 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 22:51:46

Label at a glance#

ProductGlizigen Skin Protectant
Active ingredientGLYCERIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.5%................Skin Protectant

BottleBottle

OTC - ASK DOCTOR SECTION

  • Stop use and ask a doctor if rash occurs
  • Children under 6 months: ask a doctor

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

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

OTC - QUESTIONS SECTION

  • + 34 913456902 M-F 9:00 am to 5:00 pm

INDICATIONS & USAGE SECTION

  • deodorizes, refreshes and avoids the consequences of the agressive actions of the detergents in the genital areas

DOSAGE & ADMINISTRATION SECTION

  • apply pulverizing over the genital zone keeping the container in an upright position
  • 3 or 4 applications per day used to be anough, but it can be used as often as necessary

OTC - PURPOSE SECTION

  • apply pulverizing over the genital zone keeping the container in an upright position
  • 3 or 4 applications per day used to be anough, but it can be used as often as necessary

INACTIVE INGREDIENT SECTION

Propyleneglycol, water, Polysorbate 80, Glycyrrhizinic Acid, Sodium Benzoate, Potassium Sorbate, TEA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

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
64539-004-012020-01-31C16284748780-19d75b9cf-dc3d-f424-e053-dadaa90a57ce4ef6dae3-dbf2-25bc-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-004-01Glizigen Skin Protectant60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-004GLIZIGEN SKIN PROTECTANT (GLYCERIN) SPRAY [CATALYSIS, SL]2Legacy NDC, 1 package rows20170629_4ef6dae3-dbf2-25bc-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64539-00464539-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXACTIB
PROPANEDIOL5965N8W85TIACT
TEA LEAFGH42T47V24IACT
GLYCYRRHIZIN6FO62043WKIACT

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
530af5d6-debd-487a-e054-00144ff8d46c4ef6dae3-dbf2-25bc-e054-00144ff88e882017-06-28WarningsExact identifier
spl id: 530af5d6-debd-487a-e054-00144ff8d46c
spl set id: 4ef6dae3-dbf2-25bc-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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