INSTANT HAND SANITIZER GEL- alcohol gel 
Bonita Pharmaceuticals LLC

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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Instant Hand Sanitizer Gel

Drug Facts

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

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

Other Information

Inactive Ingredients

Hand Sanitizer Gel Label

INSTANT HAND SANITIZER GEL 
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53598-007
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 9/2013
Document Id: 95fb86dd-1cd2-4fbe-9395-493cb8d932ec
Set id: e50be252-f6fc-4a3d-92a4-efc0619c3ae6
Version: 1
Effective Time: 20130912
 
Bonita Pharmaceuticals LLC