LENIFEN- lenifen cream
CONTRAD SWISS SA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

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

Package. Label Principal Display Panel

Lenifen Lenitiva

LENIFEN
lenifen cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	03/01/2019	12/31/2020

Labeler - CONTRAD SWISS SA (486203529)

Registrant - CONTRAD SWISS SA (486203529)

Name	Address	ID/FEI	Business Operations
Establishment
SIPRES SRL		440712842	manufacture(72582-005)

Revised: 7/2021

Document Id: c6fea1d0-8c42-90f6-e053-2a95a90aee90

Set id: 81dd93a4-6fc7-cb4a-e053-2a91aa0a3faf

Version: 5

Effective Time: 20210713

CONTRAD SWISS SA