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Elyptol Antimicrobial Hand Gel

Dosage form: gel
Ingredients: ALCOHOL 7mL in 10mL
Labeler: Elyptol Inc.
NDC Code: 69343-121

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.

Elyptol Antimicrobial Hand Gel

Active ingredients:

Ethyl Alcohol 70% v/v

Purpose

Skin antiseptic

Keep out reach of children
  • Supervise children under 6 years.
  • Not recommended for infants.

Uses
  • To decrease bacteria on skin.
  • Recommended for repeated use.
  • For healthcare & consumer hand hygiene.

Warnings
  • For external use only
  • Flammable.
  • Keep away from sources of fire or flame.
  • If swallowed seek medical advice or contact a Poison Control Center, immediately.

When using this product

  • Do not ingest or inhale.
  • Keep away from eyes.
  • Use undiluted.

Stop using and ask a doctor

  • If redness or irritation develops.
  • In case of eye contact, rinse eyes with water.
  • If issues persist, seek medical attention.

Directions

Saturate your hands with Elyptol. Rub together for 30 seconds, covering the front, back, between fingers, even your nails.

Other Information

Store below 30°C
Keep out of direct sunlight.

Inactive ingredients

Eucalyptus oil, Water, Glycerol, Cellulose.

INT PAT APP NO: PCT/2012/000841

Questions?

(866)701-8344

Packaging

ELYPTOL ANTIMICROBIAL HAND GEL 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69343-121
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL7 mL  in 10 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL 
WATER 
GLYCERIN 
POWDERED CELLULOSE 
Packaging
#Item CodePackage Description
1NDC:69343-121-021 BOTTLE in 1 CARTON
159 mL in 1 BOTTLE
2NDC:69343-121-031 PACKAGE in 1 CARTON
289 mL in 1 PACKAGE
3NDC:69343-121-081 BOTTLE in 1 CARTON
3236 mL in 1 BOTTLE
4NDC:69343-121-161 BOTTLE in 1 CARTON
4473 mL in 1 BOTTLE
5NDC:69343-121-341 BOTTLE in 1 CARTON
51005 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/01/2014
Labeler - Elyptol Inc. (079594781)
Establishment
NameAddressID/FEIOperations
Universal Packaging Systems, Inc.790530976manufacture(69343-121)

Revised: 11/2014
 
Elyptol Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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