BioLuxe Instant Hand Sanitizer (gel) 200 mL NDC: 77716-013-06 500 mL NDC: 77716-013-16

BioLuxe Instant Hand Sanitizer by

Drug Labeling and Warnings

BioLuxe Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sterling Perfumes Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOLUXE INSTANT HAND SANITIZER- isopropyl alcohol gel 
Sterling Perfumes Industries LLC

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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

• in children less than 2 months of age
• on open skin wounds

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

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

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

BIOLUXE INSTANT HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77716-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77716-013-06	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2020
2	NDC: 77716-013-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/24/2020	12/30/2024

Labeler - Sterling Perfumes Industries LLC (561432456)

Revised: 1/2025

Document Id: 2c413be5-58a7-c7fc-e063-6394a90a698a

34390-5

Set id: a8d9e89d-1994-6fd0-e053-2995a90a8c23

Version: 3

Effective Time: 20250121