SWISS HAND GUARD ANTISEPTIC HANDWASH ANTIBACTERIAL- alcohol gel
OPI Products In

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

Alcohol 67%

Antiseptic

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

for hand washing to decrease bacteria on the skin

recommended for repeated use

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.

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

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

shg 120

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61852-046-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2012	12/31/2021
2	NDC:61852-046-02	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2012	12/31/2021
3	NDC:61852-046-03	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2012	12/31/2021
4	NDC:61852-046-04	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2012	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/31/2012	12/31/2021

Labeler - OPI Products In (097903912)

Registrant - Coty Inc (958662223)

Name	Address	ID/FEI	Business Operations
Establishment
OPI Products Inc		967172854	manufacture(61852-046)

Revised: 1/2023

Document Id: f18a098c-c3af-4555-e053-2a95a90a7328

Set id: b574b2e3-fad2-42fa-9f8c-9a9695cf5b62

Version: 5

Effective Time: 20230105

OPI Products In