BIOSALUT HAND SANITIZER ADVANCED- alcohol gel

BioSalut Hand Sanitizer Advanced by

Drug Labeling and Warnings

BioSalut Hand Sanitizer Advanced by is a Otc medication manufactured, distributed, or labeled by Brazilian Hair Llc, PHITOTERAPHIA BIOFITOGENIA LABORATORIAL BIOTA LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

INDICATIONS & USAGE

Uses  Decrease bacteria on the skin.

Warnings

For external use only

Flammable. Keep away from heat and flame.

When using this product, ?avoid contact with eye. In case of contact, flush with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other Information  Do not store above 105°F (43°C)  May discolor some fabrics and surfaces.

INACTIVE INGREDIENT

Inactive Ingredients ?AQUA, PROPYLENE GLYCOL, GLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PARFUM, AMINOMETHYL PROPANOL, CINNAMYL ALCOHOL, HEXYL CINNAMAL, D-LIMONENE, COUMARIN, BENZYL SALICYLATE, GERANIOL, ALOE BARBADENSIS LEAF EXTRACT, SORBITOL, POTASSIUM SORBATE, SODIUM BENZOATE. AFE: 2.02.100-5

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF GERMS

Disinfects while moisturizes, leaving hands feeling refreshed.

Manufactured by : Phitoteraphia Biofitogenia Laboratorial Biota

Ltda Rua Maria de Andrade 79A . CEP 26261 - 200 Nova Iguaçu/RJ. CNPJ:

00.104.603/0001-33. Brazilian Industry  Téc. Resp:

Eni Figueiredo CRQ III 03212976  Imported and distributed in USA by: Brazilian Hair LLC. 1275

Bloomfield Ave. Bldg. 7 Unit 48 Fairfield, NJ 07004.

Ph: +1 800 519 2946 -info@embellezeusa.com - www.novexhaircare.com Origin/Origen: Brazil

Packaging

INGREDIENTS AND APPEARANCE

BIOSALUT HAND SANITIZER ADVANCED 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75753-300
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
COUMARIN (UNII: A4VZ22K1WT)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
GERANIOL (UNII: L837108USY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITOL (UNII: 506T60A25R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75753-300-09	140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/10/2020
2	NDC: 75753-300-01	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/10/2020

Labeler - Brazilian Hair Llc (009780655)

Establishment
Name	Address	ID/FEI	Business Operations
PHITOTERAPHIA BIOFITOGENIA LABORATORIAL BIOTA LTDA		678448921	manufacture(75753-300)