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NDC 49687-0011-01 Antiseptic Towelettes 0.13 g/100g Details

Antiseptic Towelettes 0.13 g/100g

Antiseptic Towelettes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by CMC Group Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	49687-0011
Product ID	49687-0011_b856bc60-6b37-5fc7-e053-2a95a90a087b
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	Antiseptic Towelettes
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100g
Substance Name	BENZALKONIUM CHLORIDE
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 49687-0011-01 (49687001101)

Pricing Information	N/A
NDC Package Code	49687-0011-1
Billing NDC	49687001101
Package	10 PATCH in 1 BOX (49687-0011-1) / .9 g in 1 PATCH
Marketing Start Date	2016-08-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d7470f98-4278-415b-92e7-9eca2036bc09 Details

DRUG FACTS

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

First Aid Antiseptic

Use:

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warnings:

For external use only.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not use:

In the eyes, or over large areas of the body.

Directions:

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive ingredient:

Purified water.

Package Labeling:

INGREDIENTS AND APPEARANCE

ANTISEPTIC TOWELETTES

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49687-0011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49687-0011-1	10 in 1 BOX	08/06/2016
1		0.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:49687-0011-0	20 in 1 KIT	08/06/2016	08/06/2016
2		0.45 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: b856bc60-6b37-5fc7-e053-2a95a90a087b

Set id: d7470f98-4278-415b-92e7-9eca2036bc09

Version: 4

Effective Time: 20210107