HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ABSOLUTE MARKETING, INC., Beaming White LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to reduce bacterial organisms on the skin.

Warnings

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

WHEN USING

Avoid contact with eyes. If contact occurs, flush eyes throughly with water.

Stop use and ask a doctor if irritation or rash develops and persists. T

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

STOP USE

Stop use and ask a doctor if irritation or rash develops and persists.

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

• Dispense a small amount onto palm of hand and rub briskly and thoroughly over surfaces of both hands until dry.
• Children under 6 years of age should be supervised while using this product.

Other information

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

Inactive ingredients

Water, Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Triethanolamine

Package Label - Principal Display Panel

PDP 78389-003-99

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78389-003
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
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)	0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)	0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.65 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78389-003-99	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020

Labeler - ABSOLUTE MARKETING, INC. (117483207)

Registrant - ABSOLUTE MARKETING, INC. (117483207)

Establishment
Name	Address	ID/FEI	Business Operations
Beaming White LLC		019910700	manufacture(78389-003)