EPHYREL- skin protectant and cleansing gel

EPHYREL by

Drug Labeling and Warnings

EPHYREL by is a Otc medication manufactured, distributed, or labeled by CONTRAD SWISS SA, SIPRES SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Glycerine 2,5%

PURPOSE

Skin Protectant

USES

Temporarily protects and helps relieve minor skin irritation

Intimate cleanser with protective, moisturizing and soothing action

WARNINGS

For External Use Only

Avoid contact with eyes

Stop use and ask doctor if

• Condition Worsens
• Symptoms last more than 7 days

Keep out of reach of children.

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

Keep Out Reach of Children

DIRECTIONS

Apply as needed.

• Children under 6 months: ask a doctor

Apply a small quantity of product (press twice on the dispenser) on wet skin and gently massage. Rinse off and dry carefully

OTHER INFORMATION

Store at room temperature 20-25◦C (68-77◦F) in a dry place, out of direct sunlight.

INACTIVE INGREDIENTS

Acrylates/Vinyl isodecanoate crosspolymer, Aqua, Butylene Glycol, Caprylhydroxamic acid, Cocamidopropyl betaine, Disodium Laureth Sulfosuccinate, Fucus Vesiculosus Extract, Gluconolactone, Hydroxyphenyl propamidobenzoic acid, Lactic Acid, Maltodextrin, Parfum, Pentylene glycol, Phenethyl Alcohol, Sodium Hyaluronate, Silica, Sodium Hydroxide, Tetrasodium EDTA

QUESTIONS?

info@contrad.ch

ADVERSE REACTIONS

To report suspected adverse reactions contact 1-800-332-1088

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EPHYREL 
skin protectant and cleansing gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72582-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.65 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
LACTIC ACID (UNII: 33X04XA5AT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72582-004-02	1 in 1 CARTON	03/01/2019
1		20 g in 1 BOTTLE, DISPENSING; 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	03/01/2019

Labeler - CONTRAD SWISS SA (486203529)

Registrant - CONTRAD SWISS SA (486203529)

Establishment
Name	Address	ID/FEI	Business Operations
SIPRES SRL		440712842	manufacture(72582-004)

Establishment
Name	Address	ID/FEI	Business Operations
CONTRAD SWISS SA		486203529	label(72582-004)