ADVANCED HAND SANITIZER- alcohol gel

Advanced Hand Sanitizer by

Drug Labeling and Warnings

Advanced Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by DEALMED MEDICAL SUPPLIES LLC, PELICAN GROUP LLC, THE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin that can cause disease. recommended for repeat use

Warnings

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

Do not use

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

WHEN USING

Do not use in or near the eyes. in case of contact, rinse thorougly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

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

• Place enough product in your palm to thorougly cover your hands. Rub hands together until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110FC (43C)
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Carprylyl Glycol, Aloe Vera, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Yellow 5 and Blue 1.

Package Label - Principal Display Panel

3.78 L NDC: 78257-919-01

INGREDIENTS AND APPEARANCE

ADVANCED HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78257-919
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
CARBOMER 940 (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78257-919-01	3780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/16/2020

Labeler - DEALMED MEDICAL SUPPLIES LLC (078864775)

Establishment
Name	Address	ID/FEI	Business Operations
PELICAN GROUP LLC, THE		078435913	manufacture(78257-919)