FDA.reportPublic FDA data

Glyzigen Single Dose Intimate Gel

Manufacturer
Catalysis, SL
Effective date
2018-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:08

Label at a glance#

ProductGlyzigen Single Dose Intimate Gel
Active ingredientGLYCERIN
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - ASK DOCTOR SECTION

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

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.

INDICATIONS & USAGE SECTION

  • Apply a small amount the intimate parts and gently wash. Rinse with water
  • Maybe used as often as necessary

OTC - PURPOSE SECTION

  • Apply a small amount the intimate parts and gently wash. Rinse with water
  • Maybe used as often as necessary

OTC - ASK DOCTOR SECTION

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

OTC - QUESTIONS SECTION

+ 34 913456902 Monday to Friday: 9:00 am to 5:00 pm

OTHER SAFETY INFORMATION

  • keep the product in a cool and dry place

DOSAGE & ADMINISTRATION SECTION

  • Apply a small amount the intimate parts and gently wash. Rinse with water
  • Maybe used as often as necessary

INACTIVE INGREDIENT SECTION

Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Lactic Acid, Diazolidinyl Urea, Glycyrrhizinic,Acid, Sodium Benzoate, Potassium Sorbate, Phytosphingosine HCl, Parfum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Glyzigen Single Dose

Single useSingle use

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-007-022020-01-31C16284748780-19d75b9cf-ebdc-f424-e053-dadaa90a57ceGlyzigen single dose Intimate Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-007-01Glyzigen Single Dose Intimate Gel5 mL in 1 DOSE PACKGEL51
64539-007-02Glyzigen Single Dose Intimate Gel1 in 1 PACKAGEGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-007GLYZIGEN SINGLE DOSE INTIMATE GEL (GLYCERIN) GEL [CATALYSIS, SL]1Legacy NDC, 2 package rows20180112_628d633c-6f68-e9d1-e053-2991aa0a2986.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64539-00764539-007-01, 64539-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCYRRHIZIN6FO62043WKIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCERINPDC6A3C0OXACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
LACTIC ACID33X04XA5ATIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT

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
628d633c-6f69-e9d1-e053-2991aa0a2986628d633c-6f68-e9d1-e053-2991aa0a29862018-01-11WarningsExact identifier
spl id: 628d633c-6f69-e9d1-e053-2991aa0a2986
spl set id: 628d633c-6f68-e9d1-e053-2991aa0a2986

Reported adverse events (FAERS/openFDA)#

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