Uses

* Helps eliminate bacterias on the hand. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

Active Ingredient

Active Ingredient Purpose

Ethyl Alcohol 65%...................................Antiseptic

Warnings

For external use only-
When using this product keep out o f eyes. In case of contact, flush with water several minutes.
Keep out of reach of children except under adult supervision
If swalow get medical help or contact a Poison Control Center right away.
Flammable: Keep away from heat and flame.
Stop use and ask Doctor: if skin irritation develops.
Do not swalow
Children under 6 years old should be supervised when using this product

Stop use and ask a doctor if

* Irritation develops

Keep out of reach of children

Keep out of reach of children. In case of incidental ingestion, see professional advice or contact a Poison Control Center inmediately.

Directions

Directions:

Place enough product in your palm to throughly cover your hands.
Rub hands together briskly until dry

Inactive Ingredients

Water Carbomer, Triethanolamine, Olea Europaea Fruit Oil, Panthenol, Glycerin, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower/Leaf Extract, Rosmarinus Officinalis Leaf Extract, Thymus Vulgaris Leaf Oil, Linum Usitatissimum Seed Oil, Tocopheryl acetate (Vitamina E), Hydroxypropyl methylcellulose, Ethyl Lauroyl Arginate, Propylene Glycol, Fragrance, Phenoxyethanol, Ethylhexylglycerin, Citric Acid

Questions?

QUESTIONS OR COMMENTS: (574) 4448438 Ext 108 (Monday to Friday) 6:30 am to 4:30 pm (UTC/GMT 5 hours)

Uses

* Helps eliminate bacteria on the hand. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

Hand Sanitizer

Label

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79894-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)	0.4 mL in 100 mL
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)	0.01 mL in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.3 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.5 mL in 100 mL
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)	0.3 mL in 100 mL
THYMUS VULGARIS LEAF (UNII: GRX3499643)	0.1 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1 mL in 100 mL
HYPROMELLOSES (UNII: 3NXW29V3WO)	0.1 mL in 100 mL
PROPANEDIOL (UNII: 5965N8W85T)	0.2 mL in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.72 mL in 100 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)	0.3 mL in 100 mL
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)	0.3 mL in 100 mL
LINUM USITATISSIMUM WHOLE (UNII: 310OJT00CG)	0.1 mL in 100 mL
ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)	0.1 mL in 100 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.07 mL in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.1 mL in 100 mL
WATER (UNII: 059QF0KO0R)	29.79 mL in 100 mL
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)	0.1 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
CAMELLIA OIL (UNII: T1PE06G0VE)	0.3 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79894-006-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/29/2020

Labeler - SAMARA COSMETICS S.A.S. (881793172)

Registrant - SAMARA COSMETICS S.A.S. (881793172)

Name	Address	ID/FEI	Business Operations
Establishment
SAMARA COSMETICS S.A.S.		881793172	manufacture(79894-006)