INSTANT HAND SANITIZER GEL- ethyl alcohol gel

Instant Hand Sanitizer Gel by

Drug Labeling and Warnings

Instant Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Bonita Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

• To help decrease bacteria on the skin.
• Recommended for repeated use.

Warnings

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

• Keep out of eyes. In case of eye contact, flush it thoroughly with water, seek medical attention immediately.
• Avoid contact with broken skin.

• Stop use and ask a doctor if redness or Irritation develops and persists for more than 72hrs.

• Keep away from children. If swallowed, seek medical attention immediately. Children must only use this product under adult supervision.

Direction

• Place small amount of Bonita sanitizer in your palm. Thoroughly spread on both hands and rub together until dry.

Other Information

• Store below 105 ˚F.
• May discolor some fabrics.

Inactive Ingredients

• Water
• Propylene glycol
• Isopropyl alcohol
• PEG-12
• Carbomer 940
• Fragrance
• Triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53598-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.6 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53598-007-01	30 mL in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/12/2013

Labeler - Bonita Pharmaceuticals LLC (004219442)

Establishment
Name	Address	ID/FEI	Business Operations
Bonita Pharmaceuticals LLC		004219442	label(53598-007)