FDA.reportPublic FDA data

ZYGONE

Manufacturer
ZYGONE | Fastfill Pack, Inc.
Effective date
2020-09-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:13:47

Label at a glance#

ProductZYGONE
Active ingredientGLYCERIN
Label structure8 sections

Indications and uses

relieves dryness and softens cold sores and fever blisters.

Dosage and administration

Adults and children 6 months and older   wash hands before and after applying   apply to the affected area at the first sign of a cold sore/fever blister   shake well before use   apply liberally as needed   Use five times daily Children under 6 months: ask a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

GLYCERIN 20%

PURPOSE

OTC - PURPOSE SECTION

Cold sore/fever blister treatment and skin protectant

USES

INDICATIONS & USAGE SECTION

  • relieves dryness and softens cold sores and fever blisters.

WARNINGS

WARNINGS SECTION

For external use only

Do not use

  • if you are allergic to any ingredients in this product

When using this product

  • do not use in or near the eyes
  • do not share this product with anyone. This may spread infection.

Stop use and ask a doctor if

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

Do not use

  • on deep or puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 months and older
  •   wash hands before and after applying
  •   apply to the affected area at the first sign of a cold sore/fever blister
  •   shake well before use
  •   apply liberally as needed
  •   Use five times daily
  • Children under 6 months: ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Barbadensis Juice Extract, Cape Aloe Extract, Propolis Extract, Rosa Canina (Rose Hip) Fruit Extract, Water(Aqua)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0-Artwork_UC_Zygone_front0-Artwork_UC_Zygone_front

0-Artwork_UC_Zygone_back0-Artwork_UC_Zygone_back

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72699-10172699-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALOE FEROX LEAF0D145J8EMEIACT
PROPOLIS WAX6Y8XYV2NOFIACT
ROSA CANINA FRUIT3TNW8D08V3IACT
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
c41f8c58-d413-52f8-e053-2995a90a548e31bcb9e8-8f05-4512-8749-eabdf9e190312021-06-06WarningsExact identifier
spl set id: 31bcb9e8-8f05-4512-8749-eabdf9e19031

Reported adverse events (FAERS/openFDA)#

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