ALCOHOL PREP PAD MEDIUM- isopropyl alcohol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Available from:

Kentron HealthCare, Inc.

INN (International Name):

ISOPROPYL ALCOHOL

Composition:

ISOPROPYL ALCOHOL 70 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic For preparation of skin prior to injection

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL PREP PAD MEDIUM- ISOPROPYL ALCOHOL LIQUID
KENTRON HEALTHCARE, INC.
----------
ALCOHOL PREP PAD, MEDIUM
DRUG FACTS
ACTIVE INGREDIENT
Isopropyl Alcohol, 70% v/v
PURPOSE
Antiseptic
USE
For preparation of skin prior to injection
WARNINGS
For external use only. Flammable, keep away from the fire or flame.
DO NOT USE
with electrocautery procedures
in the eyes.
STOP USE
if irritation or redness develop. If your condition persists for more
than 72 hours,
consult a doctor.
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
INACTIVE INGREDIENT
purifed water
PACKAGE LABEL
Qty. 1 ea Alcohol Prep Pad
Antiseptic Sterile, Medium, 2 Ply Saturated with 70% Isopropyl Alcohol
Sterile if unopened, undamaged
FOR EXTERNAL USE ONLY
Manufactured for:
Kentron Health Care, Inc
Springfield, TN 37172
Made in Chine
www.kentronmedical.com
ALCOHOL PREP PAD MEDIUM
isopropyl alcohol liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69556-650
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Kentron HealthCare, Inc.
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL -
UNII:ND2M416302)
ISOPROPYL
ALCOHOL
70 mL
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:69556-650-
16
1 in 1 PACKET
01/22/2015
1
50 mL 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 Drug
M003
01/22/2015
LABELER -
Kentron HealthCare, Inc. (618825723)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Wuxi Medical Instrument Factory
421292863
manufacture(69556-650)
Revised: 10/2023