ZYGONE- glycerin solution

ZYGONE by

Drug Labeling and Warnings

ZYGONE by is a Otc medication manufactured, distributed, or labeled by ZYGONE, Fastfill Pack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

GLYCERIN 20%

PURPOSE

Cold sore/fever blister treatment and skin protectant

USES

• relieves dryness and softens cold sores and fever blisters.

WARNINGS

For external use only

• When using this product
• Do not get into eyes
• 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 pucture wounds
• animal bites
• serious burns

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Children under 6 months: ask a doctor
• shake well
• apply as needed
• rub in gently
• wash hands before and after application
• do not share this product with anyone.

INACTIVE INGREDIENTS

lcohol, aloe barbadensis juice extract, cape aloe extract, propolis extract , rosa canina (rose hip) fruit extract, water/aqua.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZYGONE 
glycerin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72699-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALOE FEROX LEAF (UNII: 0D145J8EME)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72699-101-11	4 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	02/19/2019

Labeler - ZYGONE (831859793)

Establishment
Name	Address	ID/FEI	Business Operations
Fastfill Pack, Inc.		079348840	manufacture(72699-101)