LENIFEN by CONTRAD SWISS SA / SIPRES SRL LENIFEN cream

LENIFEN by

Drug Labeling and Warnings

LENIFEN 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

Active ingredient Purpose

Glycerin 5% Skin protectant

Avenanthramides 0,05% Skin protectant

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

• rashes
• eczema

Warnings

Avoid contact with eyes

Stop use and ask doctor if

condition worsen, symptoms persist for more than 7 days, or clear up and occur again within a few days.

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

Directions

Apply as needed.

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

Beheneth-25, butylated hydroxytoluene, Butylene Glycol, Citric Acid, Dicaprylyl Ether, Disodium Edta, Hydrogenated Polyisobutene, Isopropyl Myristate, Oleyl Alcohol, Pentaerythrityl Distearate, Pentylene glycol, Phenoxyethanol,Simmondsia Chinensis Seed Oil, Sodium Polyacrylate, Sucrose Polystearate, Tocopheryl Acetate, Triticum Vulgare Germ Oil, Water, Zanthoxylum Bungeanum Fruit Extract.

Questions?

info@contrad.ch

ADVERSE REACTIONS

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

Package. Label Principal Display Panel

INGREDIENTS AND APPEARANCE

LENIFEN 
lenifen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72582-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENANTHRAMIDES (UNII: 5PA41O4AIT) (AVENANTHRAMIDES - UNII:5PA41O4AIT)	AVENANTHRAMIDES	0.05 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
SUCROSE DISTEARATE (UNII: 33X4X4B90S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHEAT GERM (UNII: YR3G369F5A)
WATER (UNII: 059QF0KO0R)
ZANTHOXYLUM ARMATUM FRUIT (UNII: ER3FV125H7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
BEHENETH-25 (UNII: 0G17KJ5M7P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72582-005-02	1 in 1 CARTON	03/01/2019
1		1 in 1 TUBE
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not 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(72582-005)

Establishment
Name	Address	ID/FEI	Business Operations
CONTRAD SWISS SA		486203529	label(72582-005)