HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Exelencia Importers, Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Uses

Decreases bacteria on skin that pontetially can cause disease

Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from heat or flame

When using this product, avoid contact with eyes, ears and mouth. In case of contact with eyes flush thoroughly with water.

Do not use

• In children less than 2 months of age.
• On open skin wounds.

WHEN USING

When using this product, avoid contact with eyes, ears, and mouth. In case of contact with eyes flush thoroughly with water.

Stop use and ask a doctor if redness or irritation develops & persists for more than 72 hours.

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

STOP USE

Stop use and ask a doctor if redness or irritation develops & persits for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Wet hands thoroughly with product and allow to dry.
• Children under 6 years of age, use only under adult supervision.

Inactive ingredients

Water (Aqua), Carbomer, Triethanolamine, Fragrance (Parfum), Phospholipids, Polyquaternium-16, BHT, Panthenol, Niacinamide, Dimethicone, Bisabolol, Phenoxyethanol, Tocopheryl Acetate, CI 16035

Fromsoybean lecithin. FD&C RED 40.

Other Information

Do not store above 105F (43C).

May discolor some fabrics and surfaces.

PRINCIPAL DISPLAY PANEL

EXEL

ALCOHOL EN GEL ANTIMICROBIANO

con liposomas humectantes y suavizantes

ALCOOL GEL ANTIMICROBIANO

com lipossomas de acao humectante e suavizante

HAND SANITIZER

with moisturizing and softening liposomes

BIOCOSMETICA PROFESIONAL

1.69 fl. Oz/50 ml e

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53863-002
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
POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5)) (UNII: 1KX12A42IJ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PANTHENOL (UNII: WV9CM0O67Z)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
NIACINAMIDE (UNII: 25X51I8RD4)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53863-002-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2020
2	NDC: 53863-002-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2020
3	NDC: 53863-002-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2020
4	NDC: 53863-002-04	475 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2020
5	NDC: 53863-002-05	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/03/2020

Labeler - Exelencia Importers, Corp. (147644335)

Establishment
Name	Address	ID/FEI	Business Operations
Biocosmetica Exel Argentina SRL		971813332	manufacture(53863-002)