ELYPTOL ANTIMICROBIAL RUB- ethanol solution

Elyptol Antimicrobial Rub by

Drug Labeling and Warnings

Elyptol Antimicrobial Rub by is a Otc medication manufactured, distributed, or labeled by Elyptol Inc., 220 Laboratories Inc., ELYPTOL PTY. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

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.

SPL UNCLASSIFIED SECTION

INT PAT APP NO: PCT/2012/000841

Questions?

(866)701-8344

Packaging

INGREDIENTS AND APPEARANCE

ELYPTOL ANTIMICROBIAL RUB 
ethanol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69343-221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	7 mL  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69343-221-02	1 in 1 CARTON	11/01/2014
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69343-221-03	1 in 1 CARTON	11/01/2014
2		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69343-221-08	1 in 1 CARTON	11/01/2014
3		236 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69343-221-16	1 in 1 CARTON	11/01/2014
4		473 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69343-221-34	1 in 1 CARTON	11/01/2014
5		1005 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/01/2014

Labeler - Elyptol Inc. (079594781)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc. (DBA: PakLab)		790530976	manufacture(69343-221)