Your browser does not support JavaScript! INSTANT HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [BONITA PHARMACEUTICALS LLC]
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INSTANT HAND SANITIZER GEL (ethyl alcohol) gel
[Bonita Pharmaceuticals LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

Hand Sanitizer Gel Label

INSTANT HAND SANITIZER GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53598-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL18.6 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
ISOPROPYL ALCOHOL 
POLYETHYLENE GLYCOL 600 
CARBOMER 940 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53598-007-0130 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/12/2013
Labeler - Bonita Pharmaceuticals LLC (004219442)
Establishment
NameAddressID/FEIBusiness Operations
Bonita Pharmaceuticals LLC004219442label(53598-007)

Revised: 9/2013
 
Bonita Pharmaceuticals LLC

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