HAND SANITIZER- isopropyl alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Penseur Products Group LLC, PENSEUR PRODUCTS GROUP LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

ANTIMICROBIAL

Use

First Aid to help prevent the risk of infection in minor cuts, scrapes, and burns.

Warnings

For external use only.

If taken internally, serious gastric disturbances will result.

Flammable. Keep away from fire or flame

Use only in a well ventiralted area, fumes may be toxic.

Do not use

deep or puncture wounds, animal bites, or serious burns.

WHEN USING

When using this product do not get into eyes.

Do not apply over large areas of the body.

do not use longer than one week unless directed by a doctor.

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222) or (911).

STOP USE

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

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

Directions

• clean affected area
• apply small amounts of this product on the area 1-3 times daily.
• if bandaged, let dry first
• may be covered with a sterile bandage.

Other information

• Store at room temperature
• does not contain, nor is intended as a substitute for grain or ethyl alcohol.

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

236 ml NDC: 79878-005-00

946 ml NDC: 79878-005-01

3785 ml NDC: 79878-005-02

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79878-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

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: 79878-005-00	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
2	NDC: 79878-005-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020
3	NDC: 79878-005-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/24/2020

Labeler - Penseur Products Group LLC (117584143)

Registrant - Penseur Products Group LLC (117584143)

Establishment
Name	Address	ID/FEI	Business Operations
PENSEUR PRODUCTS GROUP LLC		117584143	manufacture(79878-005)