QUALGEN Isopropyl Alcohol Antiseptic 75%

QUALGEN Isopropyl Alcohol Antiseptic by

Drug Labeling and Warnings

QUALGEN Isopropyl Alcohol Antiseptic by is a Otc medication manufactured, distributed, or labeled by Qualgen LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

QUALGEN ISOPROPYL ALCOHOL ANTISEPTIC- isopropyl alcohol solution 
Qualgen LLC

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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QUALGEN Isopropyl Alcohol Antiseptic 75%

DRUG FACTS

Active Ingredient(s)

Isopropyl Alcohol 75% v/v

Purpose

Antiseptic

Use(s)

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

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

glycerin, hydrogen peroxide, water

Qualgen 14844 Bristol Park Blvd Edmond OK 73013

PH: (877-780-3369)

Package Label - Principal Display Panel

Qualgen

14844 Bristol Park Blvd.
Edmond. OK 73013
877-780-3369

Oklahoma's #1 Compounding Pharmacy

Isopropyl Alcohol Antiseptic 75%
Topical Solution
Hand Sanitizer - Non-sterile solution

FOR EXTERNAL USE ONLY

32 Oz

LOT#:    HSL-

CPD:

res

QUALGEN ISOPROPYL ALCOHOL ANTISEPTIC 
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69761-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69761-001-16	0.47 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/28/2020
2	NDC: 69761-001-32	0.94 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/28/2020
3	NDC: 69761-001-28	3.79 L in 1 JUG; Type 0: Not a Combination Product	03/28/2020
4	NDC: 69761-001-55	208.2 L in 1 DRUM; Type 0: Not a Combination Product	03/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/28/2020	10/04/2021

Labeler - Qualgen LLC (034474862)

Revised: 9/2021

Document Id: cd00e9f7-2080-73f2-e053-2a95a90a1101

34390-5

Set id: aac394a8-091f-42a2-b1f6-575ce0ecadc8

Version: 4

Effective Time: 20210927