SANITELLE ADVANCED HAND SANITIZER WITH MACADAMIA OIL- alcohol gel

Sanitelle Advanced Hand Sanitizer with Macadamia Oil by

Drug Labeling and Warnings

Sanitelle Advanced Hand Sanitizer with Macadamia Oil by is a Otc medication manufactured, distributed, or labeled by BENTUS LABORATORII, OOO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

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.

STOP USE

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

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

Water, Propylene Glycol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Macadamia Ternifolia Nut Oil, Fragrance

Package Label - Principal Display Panel

50 mL NDC: 80068-004-50

Distibuted by: Flex Technologies, Inc, 10432 Balls Ford Rd. Suite 300, Manassas, VA 20109, USA

INGREDIENTS AND APPEARANCE

SANITELLE ADVANCED HAND SANITIZER WITH MACADAMIA OIL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80068-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MACADAMIA OIL (UNII: 515610SU8C)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80068-004-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/19/2021

Labeler - BENTUS LABORATORII, OOO (354757383)

Establishment
Name	Address	ID/FEI	Business Operations
BENTUS LABORATORII, OOO		354757383	manufacture(80068-004)