Hand Sanitizer Gel by Ulano Corporation

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Ulano Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL- alcohol gel 
Ulano Corporation

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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Active Ingredient(s) Ethyl Alcohol min 78% v/v

Drug Facts Panel

Drug Facts

Active Ingredient(s) Purpose

Ethyl Alcohol min 78% v/v............................................Antiseptic

Purpose

Antiseptic

Use

Hand sanitizer gel to decrease viruses and bacteria that can potentially cause desease.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

  • on open skin wounds
  • in children under 1 year of age

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 more serious condition.

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

Directions

  • Place bead of product onto dry palms.
  • Spread evenly to cover hands.
  • Rub lightly until dry.
  • Children under 6 years should be supervised when using this product.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin USP, Purified water, HydroxyPropylCellulose, Hydrogen Peroxide, Lemon(Citrus limon) Peel Oil distilled, Linalool, Linalyl Acetate

Package Label - Principal Display Panel

90 mL NDC: 80757-010-01

Principal Display panel

HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80757-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL78.3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LINALYL ACETATE (UNII: 5K47SSQ51G) 0.03 mL  in 100 mL
LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.0287 mL  in 100 mL
LEMON OIL, DISTILLED (UNII: ET5GD00TRP) 0.083 mL  in 100 mL
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) 1.7345 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.026 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.0278 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 18.77 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80757-010-0190 mL in 1 TUBE; Type 0: Not a Combination Product10/23/202012/31/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/02/202012/31/2021
Labeler - Ulano Corporation (046806204)
Registrant - Ulano Corporation (046806204)
Establishment
NameAddressID/FEIBusiness Operations
Ulano Corporation046806204manufacture(80757-010)

Revised: 12/2021
 

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