ELYPTOL ANTIMICROBIAL RUB- ethanol solution 
Elyptol Inc.

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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Elyptol Antimicrobial Rub

Active ingredients:

Ethyl Alcohol 70% v/v

Purpose

Skin antiseptic

Keep out reach of children

Uses

Warnings

Flammable.

When using this product

Stop using and ask a doctor

Directions

• HAND SANITISER/SKIN ANTISEPTIC: Apply Elyptol evenly and rub for 30 seconds.
• SURGICAL HAND DISINFECTION: Apply Elyptol from forearms to fingertips. Rub evenly for 3 minutes, including between fingers and over nails.
• PRE-OPERATIVE SKIN PREPARATION AND SKIN ANTISEPSIS: Apply Elyptol and rub evenly over desired area for 30 seconds.

Other Information

Store below 30°C
Keep out of direct sunlight.

Inactive ingredients

Eucalyptus oil, Water, Glycerol, Cellulose, Piroctone Olamine.

INT PAT APP NO: PCT/2012/000841

Questions?

(866)701-8344

Packaging

image description

ELYPTOL ANTIMICROBIAL RUB 
ethanol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69343-221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7 mL  in 10 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69343-221-021 in 1 CARTON11/01/2014
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69343-221-031 in 1 CARTON11/01/2014
289 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69343-221-081 in 1 CARTON11/01/2014
3236 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69343-221-161 in 1 CARTON11/01/2014
4473 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:69343-221-341 in 1 CARTON11/01/2014
51005 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/01/2014
Labeler - Elyptol Inc. (079594781)
Establishment
NameAddressID/FEIBusiness Operations
220 Laboratories LLC.783247950manufacture(69343-221)

Revised: 12/2022
Document Id: c47506d3-a699-4f9a-b9bd-6f26219d8fa0
Set id: a6903410-ab88-4634-9937-4b2d00e07915
Version: 6
Effective Time: 20221219
 
Elyptol Inc.