OTC Medication Information: Sterile Alcohol Prep Pads

STERILE ALCOHOL PREP PADS- isopropyl alcohol cloth
Zhejiang Qimei Cosmetics 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.

Isopropyl Alcohol, 70% V/V

Purpose

Antiseptic

Use for preparation of the skin prior to injection

Warnings

For external use only • Flammable, keep away from fire or flame •

Do not use: with electrocautery or in eyes •

Stop use: if redness or irrigation develops, if condition continues for more than 72 hours consult a physician. •

Keep out of reach from children: If swallowed, get medical attention or call Poison Control immediately.

Directions

Apply alcohol as needed to clean intended area. Discard after single use.

Inactive ingredients

30% purified water.

Other information

store at 15-30°C (59-86°F

NDC: 81773-012-01

STERILE ALCOHOL PREP PADS 70% isopropyl alcohol cloth

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81773-012 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:81773-012-01 1 PATCH in 1 BAG contains a PATCH 1 0.176 mL in 1 PATCH This package is contained within the BAG (81773-012-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/15/2023

Labeler — Zhejiang Qimei Cosmetics Co., Ltd. (709887693)

Registrant — Zhejiang Qimei Cosmetics Co., Ltd. (709887693)

Establishment
Name	Address	ID/FEI	Operations
Zhejiang Qimei Cosmetics Co., Ltd.		709887693	manufacture (81773-012)

Revised: 09/2023 Zhejiang Qimei Cosmetics Co., Ltd.