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.

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AlphaProMed AlphaCol Sterile Isopropyl Alcohol Preparation Pad

Isopropyl 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

Label1 Label2

ALPHAPROMED ALPHACOL STERILE ISOPROPYL ALCOHOL PREPARATION PAD
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81444-002
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81444-002-01	1 in 1 PACKAGE	06/23/2020
1		2.7 mL in 1 PATCH; Type 0: Not a Combination Product

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

Labeler - Bay Promo, LLC (080790703)

Name	Address	ID/FEI	Business Operations
Establishment
QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.		529667276	manufacture(81444-002)