BSAFE3 HAND SANITIZER- alcohol gel

BSAFE3 Hand Sanitizer by

Drug Labeling and Warnings

BSAFE3 Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Suite K Value Added Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin that could cause disease 
• recommended for repeated use

Warnings

For external use only-hands

Flammable. Keep away from heat and flame

When using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water
• avoid contact with broken skin 
• do not inhale or ingest

Stop use and ask a doctor if

• irritation or redness develops 
• condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away

Directions

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6, use under adult supervision
• not recommended for infants

Other Information

• do not store above 105°F
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

Water (aqua), Carbomer, Glycerin, Aloe Barbadensis Leaf Juice, Sodium Hydroxide

Package Labeling:

INGREDIENTS AND APPEARANCE

BSAFE3 HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68957-2000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68957-2000-0	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - Suite K Value Added Services LLC (036822144)

Establishment
Name	Address	ID/FEI	Business Operations
Suite K Value Added Services LLC		036822144	manufacture(68957-2000)