ALCOHOL HAND SANITIZER - isopropyl alcohol gel 
Seatex Ltd

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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Drug Facts

Active Ingredient................Purpose

Isopropyl Alcohol 70%................Antiseptic

Uses

For hand sanitizing to decrease bacteria on the skin.

Warnings

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

Do not use in the eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops, 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.

Directions

  • Place enough product in your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Carbomer, Fragrance, Aminomethylpropanol and Propylene Glycol.


Other Information

  • Store at 20˚ to 25˚C (68˚ to 77˚F).
  • May discolor certain fabrics or surfaces.

Manufactured by Seatex Ltd, Rosenberg, Texas 77471


label

cbi label

ALCOHOL HAND SANITIZER 
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76250-641
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL700 g  in 1 kg
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL 
WATER 
CARBOMER HOMOPOLYMER TYPE C 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:76250-641-022 in 1 BOX
1NDC:76250-641-044 in 1 BOX
1NDC:76250-641-641.81 kg in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34409/07/2011
Labeler - Seatex Ltd (026647404)
Registrant - Seatex Ltd (026647404)
Establishment
NameAddressID/FEIBusiness Operations
Seatex Ltd026647404manufacture

Revised: 09/2011
 
Seatex Ltd