SWISS HAND GUARD ANTISEPTIC HANDWASH ANTIBACTERIAL- alcohol gel

swiss hand guard by

Drug Labeling and Warnings

swiss hand guard by is a Otc medication manufactured, distributed, or labeled by OPI Products In, Coty Inc, OPI Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 67%

PURPOSE

Antiseptic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

for hand washing to decrease bacteria on the skin

recommended for repeated use

WARNINGS

For external use only

Flammable, keep away from fire or flame

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

Stop use and consult a physician if irritation and redness develop and persist for more than 72 hours.

DOSAGE & ADMINISTRATION

to be used without water

place a small amount of products in the hand

spread over both hands and rub into the skin until dry

INACTIVE INGREDIENT

Water, Carbomer Sorbitol, Ethyhexyl Palmitate, Mentha Piperita (Peppermint) Oil, Menthol, Eucalyptus Globulus Leaf Oil, Tromethamine, Drometrizole, Limonene, Linalool, CI 17200 (Red 33).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SWISS HAND GUARD  ANTISEPTIC HANDWASH ANTIBACTERIAL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61852-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	80.4 mL  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Ethylhexyl Palmitate (UNII: 2865993309)
Peppermint Oil (UNII: AV092KU4JH)
Menthol (UNII: L7T10EIP3A)
Eucalyptus Oil (UNII: 2R04ONI662)
Tromethamine (UNII: 023C2WHX2V)
Drometrizole (UNII: 5X93W9OFZL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61852-046-01	120 mL in 1 BOTTLE
2	NDC: 61852-046-02	240 mL in 1 BOTTLE
3	NDC: 61852-046-03	480 mL in 1 BOTTLE
4	NDC: 61852-046-04	960 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	01/31/2012

Labeler - OPI Products In (967172854)

Registrant - Coty Inc (958662223)

Establishment
Name	Address	ID/FEI	Business Operations
OPI Products Inc		967172854	manufacture