Isopropyl Alcohol: Package Insert and Label Information

ISOPROPYL ALCOHOL- isopropyl alcohol swab
Mazza Healthcare, 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.

Active ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use

• for preparation of the skin prior to an injection

Warnings

For external use only.

Flammable: keep away from fire or flame.

Do not use

• with electrocautery procedures
• in the eyes; if contact occurs, flush eyes with water

Discontinue use if irritation and redness develop.

Stop use and consult a doctor if the condition persists for more than 72 hours.

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

Directions

• for preparation of the skin prior to an injection, wipe injection site vigorously

Other information

Store at room temperature 59-86ºF (15-30ºC).

Inactive ingredients

water

Mazza Healthcare, LLC
1-877-629-9242

Principal Display Panel — 500 Pouch Carton Label

MH

Mazza Healthcare

MODEL NO.: 02-033-00

DESCRIPTION: ALCOHOL SWABSTICKS, 4” SATURATED, NON-STERILE

QUANTITY: 1 CASE (500 POUCHES X 3 EACH)

LOT NO.:

MANUFACTURE DATE:

EXPIRY DATE:

MANUFACTURED FOR:

Mazza Healthcare, LLC

Bannockburn, IL 60015 • USA

MADE IN CHINA

NDC 81280-001-03

Principal Display Panel — 3 Applicators Pouch Label

MH

Mazza Healthcare

Alcohol Swabsticks

NDC 81280-001-03

70% Isopropyl Alcohol • Antiseptic

4” Saturated • Non-Sterile • Single Use Only

3/pouch

Reorder Number 02-033-00

Principal Display Panel — 500 Pouch Carton Label

MH

Mazza Healthcare

MODEL NO.: 02-031-00

DESCRIPTION: ALCOHOL SWABSTICKS, 4” SATURATED, NON-STERILE

QUANTITY: 1 CASE (500 POUCHES X 1 EACH)

LOT NO.:

MANUFACTURE DATE:

EXPIRY DATE:

MANUFACTURED FOR:

Mazza Healthcare, LLC

Bannockburn, IL 60015 • USA

MADE IN CHINA

NDC 81280-001-01

Principal Display Panel — 1 Applicator Pouch Label

MH

Mazza Healthcare

Alcohol Swabstick

NDC 81280-001-01

70% Isopropyl Alcohol • Antiseptic

4” Saturated • Non-Sterile • Single Use Only

1/pouch

Reorder Number 02-031-00

ISOPROPYL ALCOHOL isopropyl alcohol swab

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81280-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isopropyl Alcohol (Isopropyl Alcohol) Isopropyl Alcohol 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength Water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:81280-001-01 500 POUCH in 1 CARTON contains a POUCH 1 1 APPLICATOR in 1 POUCH This package is contained within the CARTON (81280-001-01) and contains a APPLICATOR 1 2.5 mL in 1 APPLICATOR This package is contained within a POUCH and a CARTON (81280-001-01) 2 NDC:81280-001-03 500 POUCH in 1 CARTON contains a POUCH 2 3 APPLICATOR in 1 POUCH This package is contained within the CARTON (81280-001-03) and contains a APPLICATOR 2 4.5 mL in 1 APPLICATOR This package is contained within a POUCH and a CARTON (81280-001-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 03/01/2021

Labeler — Mazza Healthcare, LLC (830069063)

Revised: 02/2021 Mazza Healthcare, LLC