AlphaProMed AlphaCol Sterile Isopropyl Alcohol Preparation Pad

AlphaProMed AlphaCol Sterile Isopropyl Alcohol Preparation Pad by

Drug Labeling and Warnings

AlphaProMed AlphaCol Sterile Isopropyl Alcohol Preparation Pad by is a Otc medication manufactured, distributed, or labeled by Bay Promo, LLC, QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALPHAPROMED ALPHACOL STERILE ISOPROPYL ALCOHOL PREPARATION PAD- alcohol cloth 
Bay Promo, 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.

----------

AlphaProMed AlphaCol Sterile Isopropyl Alcohol Preparation Pad

Alcohol 70%......................Antiseptic

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.

Stop use

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

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

Directions

Wipe topically and discard after use.

Other information

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

Water

ALPHAPROMED ALPHACOL STERILE ISOPROPYL ALCOHOL PREPARATION PAD 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81444-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81444-001-01	1 in 1 PACKAGE	06/23/2020	02/12/2021
1		2.7 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2020	02/12/2021

Labeler - Bay Promo, LLC (080790703)

Establishment
Name	Address	ID/FEI	Business Operations
QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.		529667276	manufacture(81444-001)

Revised: 2/2021

Document Id: bb26c010-29a2-3dc5-e053-2995a90a2c89

34390-5

Set id: b8ce376f-5c63-41e8-e053-2995a90afb2a

Version: 2

Effective Time: 20210212