ALCOHOL ANTISEPTIC 70% TOPICAL SOLUTION- alcohol gel

Alcohol Antiseptic 70% Topical Solution by

Drug Labeling and Warnings

Alcohol Antiseptic 70% Topical Solution by is a Otc medication manufactured, distributed, or labeled by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc, Keystone Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 70% v/v.

PURPOSE

Purpose: Antiseptic

Use(s)

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 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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

water, glycerin, isopropyl myristate, carbomer, tocopheryl acetate, triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL ANTISEPTIC 70% TOPICAL SOLUTION 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68400-489
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-489-99	995 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)

Establishment
Name	Address	ID/FEI	Business Operations
Keystone Industries		014769301	label(68400-489) , manufacture(68400-489)