ALCOHOL PREPS STERILE- isopropyl alcohol cloth

Alcohol Preps Sterile by

Drug Labeling and Warnings

Alcohol Preps Sterile by is a Otc medication manufactured, distributed, or labeled by Jianerkang Medical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

ALCOHOL PREPS STERILE 
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-0006-1	1 in 1 POUCH	08/01/2020
1		0.4 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/01/2020

Labeler - Jianerkang Medical Co., Ltd (530968767)

Establishment
Name	Address	ID/FEI	Business Operations
Jianerkang Medical Co., Ltd		530968767	manufacture(34645-0006)