BIOLUXE INSTANT HAND SANITIZER- isopropyl alcohol gel 
Sterling Perfumes Industries 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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BioLuxe Instant Hand Sanitizer (gel)
200 mL NDC: 77716-013-06
500 mL NDC: 77716-013-16

Active Ingredient(s)

Isopropyl Alcohol 75% v/v.

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 or flame

Do not use

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. These may be signs of a serious condition.

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

Directions

Other information

Inactive ingredients

Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Carbomer, Fragrance, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Water

Package Label - Principal Display Panel

Manufactured by Sterling Perfumes Industries LLC

bioLuxe Instant Hand Sanitizer (200 mL) NDC: 77716-013-06

200mL

bioLuxe Instant Hand Sanitizer (500 mL) NDC: 77716-013-16

500mL

BIOLUXE INSTANT HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77716-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77716-013-06200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
2NDC:77716-013-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/24/2020
Labeler - Sterling Perfumes Industries LLC (561432456)

Revised: 11/2020
Document Id: b55e8c09-70bb-4999-e053-2995a90a9e81
Set id: a8d9e89d-1994-6fd0-e053-2995a90a8c23
Version: 2
Effective Time: 20201130
 
Sterling Perfumes Industries LLC