BIOSALUT HAND SANITIZER ADVANCED- alcohol gel 
Brazilian Hair Llc

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.

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EMBELLEZE BioSalut Hand Sanitizer ADVANCED

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

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.

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

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

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

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

IMAGEIMAGE

BIOSALUT HAND SANITIZER ADVANCED 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75753-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75753-300-09140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
2NDC:75753-300-01300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/10/2020
Labeler - Brazilian Hair Llc (009780655)
Establishment
NameAddressID/FEIBusiness Operations
PHITOTERAPHIA BIOFITOGENIA LABORATORIAL BIOTA LTDA678448921manufacture(75753-300)

Revised: 9/2020
Document Id: a390e28b-356d-44ba-bf20-9a612ba90ed9
Set id: 821d4be7-20d1-44bb-bc05-87acc8d9782c
Version: 1
Effective Time: 20200914
 
Brazilian Hair Llc