Alcohol Prep Pad Sterile: Package Insert and Label Information

ALCOHOL PREP PAD STERILE- isopropyl alcohol patch
Jiangsu Province Jianerkang Medical Dressing Co., Ltd

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.

Drug Facts

Active Ingredients

Isopropyl Alcohol 70%

Purpose

Antiseptic Cleanser

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

Stop Use

If irritation and redness develop. If condition persists consult your health care practitioner.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

• Wipe injection site vigorously and discard

Other Information

Store at room temperature 15° — 30°C (59° — 86° F)

Inactive Ingredient

purified water

Package Labeling:

ALCOHOL PREP PAD STERILE isopropyl alcohol patch

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:34645-0005 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:34645-0005-1 1 PATCH in 1 POUCH contains a PATCH 1 0.5 mL in 1 PATCH This package is contained within the POUCH (34645-0005-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/30/2020

Labeler — Jiangsu Province Jianerkang Medical Dressing Co., Ltd (530968767)

Revised: 05/2020 Jiangsu Province Jianerkang Medical Dressing Co., Ltd