QUEEN MAX- hand sanitizer gel

QUEEN MAX by

Drug Labeling and Warnings

QUEEN MAX by is a Otc medication manufactured, distributed, or labeled by Fuson LLC, MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKET. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

• Wet hands thoroughly with product and allow to dry without wiping.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• do not store in direct sunlight
• Store below 50C/105F
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

carbomer, glycerin, triethanolamine, water

Package Label - Principal Display Panel

100 mL NDC: 78141-124-10

INGREDIENTS AND APPEARANCE

QUEEN MAX 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78141-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78141-124-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020
2	NDC: 78141-124-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/25/2020

Labeler - Fuson LLC (113376279)

Establishment
Name	Address	ID/FEI	Business Operations
MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKET		519846410	manufacture(78141-124)