Bortek Gel Hand Sanitizer

Bortek Hand Sanitizer by

Drug Labeling and Warnings

Bortek Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Bortek Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BORTEK HAND SANITIZER- ethanol gel 
Bortek Industries

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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Bortek Gel Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

Warnings

• Flammable, keep away from heat or flame
• For external use only.

Keep out of eyes, ears or mouth. In case of contact, flush eyes with water.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions

• Apply sufficient amount of product to your palm to cover both hands.
• Rub until dry.

Other information

May discolor certain fabrics and surfaces.

Inactive ingredients

Acrylates/C10/30, Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

Bortek Industries, Inc.

800.626.7835

sweeperland.com

BORTEK INDUSTRIES, INC.

Gel Hand Sanitizer

WITH ALOE VERA, VITAMIN E, & MOISTURIZERS

KILLS 99.99% OF GERMS

18 FL OZ

BORTEK HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81731-180
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
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81731-180-18	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/12/2021	04/05/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/12/2021	04/05/2023

Labeler - Bortek Industries (014184014)

Revised: 9/2022

Document Id: e99add26-2bdc-a1f7-e053-2995a90a180a

34390-5

Set id: bfcc8a7a-1985-0c47-e053-2a95a90a5ff2

Version: 2

Effective Time: 20220926