GLIZIGEN SKIN PROTECTANT- glycerin spray

Glizigen Skin Protectant by

Drug Labeling and Warnings

Glizigen Skin Protectant 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

DO NOT USE

• Do not use on damaged or broken skin.

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

QUESTIONS

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

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

• 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

PURPOSE

• 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLIZIGEN SKIN PROTECTANT 
glycerin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64539-004
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
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	0.8 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.1 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.1 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	100 mg  in 1 mL
PROPANEDIOL (UNII: 5965N8W85T)	50 mg  in 1 mL
TEA LEAF (UNII: GH42T47V24)	0.1 mg  in 1 mL
GLYCYRRHIZIN (UNII: 6FO62043WK)	0.1 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64539-004-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/07/2017

Labeler - Catalysis, SL (862795119)

Registrant - Catalysis, SL (862795119)

Establishment
Name	Address	ID/FEI	Business Operations
Catalysis, SL		862795119	manufacture(64539-004)