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NDC 49687-0012-00 Alcohol Cleansing 70 g/100g Details

Alcohol Cleansing 70 g/100g

Alcohol Cleansing is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by CMC Group Inc.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	49687-0012
Product ID	49687-0012_b85703a1-24ef-0ecf-e053-2a95a90a9a26
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Alcohol Cleansing
Proprietary Name Suffix	n/a
Non-Proprietary Name	ISOPROPYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	g/100g
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	CMC Group Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 49687-0012-00 (49687001200)

Pricing Information	N/A
NDC Package Code	49687-0012-0
Billing NDC	49687001200
Package	20 POUCH in 1 KIT (49687-0012-0) / .9 g in 1 POUCH
Marketing Start Date	2016-08-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e3985ef1-503a-4193-a5b5-7910aefa7814 Details

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:

INGREDIENTS AND APPEARANCE

ALCOHOL CLEANSING

isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49687-0012
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 g in 100 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49687-0012-0	20 in 1 KIT	08/06/2016
1		0.9 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/06/2016

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