MED NAP OBSTETRICAL - benzalkonium chloride liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Med-Nap LLC
INN (International Name):
BENZALKONIUM CHLORIDE
Composition:
BENZALKONIUM CHLORIDE 1.3 mg in 1.7 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - First aid antiseptic to help prevent skin infection in: - Minor Cuts - Scrapes - Burns - Antiseptic Cleaning - Perineal and maternity care - As an antiseptic for more than 1 week - In the eyes - Over large areas of the body - Deep or puncture wounds - Animal bites - Serious burns - If irritation and redness develop - If condition persists more than 72 hours, consult a physician
Authorization status:
OTC monograph not final
Authorization number:
59647-244-00, 59647-244-01

MED NAP OBSTETRICAL - benzalkonium chloride liquid

Med-Nap LLC

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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Med Nap OB - 244

Drug Facts

Active Ingredient

Benzalkonium Chloride, 0.13% v/v

Purpos e

Antiseptic

Keep out of reach of children

Keep out of reach of children.

If swallowed, get medical help or contact a poison Control Center right away.

Us es

First aid antiseptic to help prevent skin infection in:

Minor Cuts

Scrapes

Burns

Antiseptic Cleaning

Perineal and maternity care

Warnings

For External Use Only.

Do not use

As an antiseptic for more than 1 week

In the eyes

Over large areas of the body

Ask a doctor before use if you have

Deep or puncture wounds

Animal bites

Serious burns

Stop use

If irritation and redness develop

If condition persists more than 72 hours, consult a physician

Directions

Tear at notch

Remove towelette

Use only once

As a first aid antiseptic

Clean affected area

Apply 1 to 3 times daily

May be covered with a sterile bandage

If bandaged, let dry first

Other information

Store at room temperature

Avoid excessive heat

Inactive Ingredients

Water, Alcohol 5% v/v, Chlorothymol, Kathon CG

MED NAP OBSTETRICAL TOWELETTE

NDC # 59647-244-01

MED NAP

OBSTETRICAL TOWELETTE

100 Packets

Latex Free

Made by:

MED-NAP LLC,

Brooksville, FL 34601

www.mednap.us

Reorder No. 3302

Made in USA

MED NAP OBSTETRICAL

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 6 47-244

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

in 1.7 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

CHLO RO THYMO L (UNII: LJ25TI0 CVT)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

MAGNESIUM CHLO RIDE ANHYDRO US (UNII: 59 XN6 3C8 VM)

MAGNESIUM NITRATE (UNII: 77CBG3UN78 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 6 47-244-0 1

10 0 in 1 BOX

0 9 /0 9 /20 13

1

NDC:59 6 47-244-0 0

1.7 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Med-Nap LLC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 9 /0 9 /20 13

Labeler -

Med-Nap LLC (079086400)

Registrant -

Med-Nap LLC (079086400)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Med-Nap LLC

0 79 0 8 6 40 0

ma nufa c ture (59 6 47-244)

Revised: 10/2016

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