SENTEURS DORIENT HAND SANITIZER SDO- ethyl alcohol gel

SENTEURS DORIENT Hand Sanitizer by

Drug Labeling and Warnings

SENTEURS DORIENT Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SENTEURS D'ORIENT SARL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat and flame.

Do not use

- in children less than 2 months of age
- on open wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. If swallowed, get medical help.

Directions

- Place enough product on hands. Rub hands together until dry.
- Supervise children under 6 years when using to avoid swallowing.

Other information

Store between 15-30°C (59-86°F)

Inactive ingredients

aqua, glycerin, carbomer, linalool, benzyl alcohol, benzyl salicylate, geraniol, hexyl cinnamal, limonene.

SPL UNCLASSIFIED SECTION

Authentic Natural Sensual

Enriched with glycerin and essential oils for healthy hands and soft skin.

Helps eliminate 99.9% of germs and bacteria.

Senteurs d'Orient s.a.r.l

275, Avenue de Paris,

Beirut, Lebanon

www.senteursdorient.com

Made in Lebanon

Packaging

INGREDIENTS AND APPEARANCE

SENTEURS DORIENT HAND SANITIZER  SDO
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79958-452
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
GERANIOL (UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79958-452-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2020
2	NDC: 79958-452-03	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/04/2020

Labeler - SENTEURS D'ORIENT SARL (557922384)

Establishment
Name	Address	ID/FEI	Business Operations
SENTEURS D'ORIENT SARL		557922384	manufacture(79958-452)