GLYZIGEN SINGLE DOSE INTIMATE GEL- glycerin gel

Glyzigen Single Dose Intimate Gel by

Drug Labeling and Warnings

Glyzigen Single Dose Intimate Gel by is a Otc medication manufactured, distributed, or labeled by Catalysis, SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

ASK DOCTOR

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

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children

WARNINGS

• 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

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

PURPOSE

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

ASK DOCTOR

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

QUESTIONS

+ 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

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Glyzigen Single Dose

INGREDIENTS AND APPEARANCE

GLYZIGEN SINGLE DOSE INTIMATE GEL 
glycerin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64539-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	12 mg  in 1 mL
GLYCYRRHIZIN (UNII: 6FO62043WK)	0.1 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.1 mg  in 1 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	20 mg  in 1 mL
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)	3 mg  in 1 mL
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)	0.01 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT)	0.36 mg  in 1 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.3 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.1 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	100 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64539-007-02	1 in 1 PACKAGE	01/11/2018
1	NDC: 64539-007-01	5 mL in 1 DOSE PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/11/2018

Labeler - Catalysis, SL (862795119)

Registrant - Catalysis, SL (862795119)

Establishment
Name	Address	ID/FEI	Business Operations
Catalysis, SL		862795119	manufacture(64539-007)