ALCOHOL CLEANSING- isopropyl alcohol cloth 
CMC Group Inc.

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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Alcohol Cleansing Pads

DRUG FACTS

Active Ingredient:

Isopropyl Alcohol, 70% v/v

Purpose:

Antiseptic

Use:

For preparation of the skin before injection.

Warnings:

For external use only.

Flammable - keep away from fire or flame.

Do not use:

with electrocautery, in the eyes

Stop use

if irritation and redness develop. If condition persists for more than 72 hours, consult your 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.

Other information:

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

Inactive ingredient:

Purified water.

Package Labeling:

Alcohol cleansing

ALCOHOL CLEANSING 
isopropyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49687-0012-020 in 1 KIT08/06/2016
10.9 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/06/2016
Labeler - CMC Group Inc. (117201448)

Revised: 1/2021
Document Id: b85703a1-24ef-0ecf-e053-2a95a90a9a26
Set id: e3985ef1-503a-4193-a5b5-7910aefa7814
Version: 4
Effective Time: 20210107
 
CMC Group Inc.