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NDC 69103-5300-00 Antiseptic 1; 46 g/L; g/L Details

Antiseptic 1; 46 g/L; g/L

Antiseptic is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Provision Medical. The primary component is BENZALKONIUM CHLORIDE; BENZOCAINE.

Product Information

NDC	69103-5300
Product ID	69103-5300_7a4c6b17-2bb0-40e8-a855-4c88c7acae49
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzalkonium chloride, benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	1; 46
Active Ingredient Units	g/L; g/L
Substance Name	BENZALKONIUM CHLORIDE; BENZOCAINE
Labeler Name	Provision Medical
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69103-5300-00 (69103530000)

Pricing Information	N/A
NDC Package Code	69103-5300-0
Billing NDC	69103530000
Package	.0591 L in 1 BOTTLE, SPRAY (69103-5300-0)
Marketing Start Date	2022-07-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0f6d3ee2-9106-43f9-957a-c1cce4c38ad1 Details

Active Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Purpose

First aid antiseptic

Topical pain relief

Uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Warnings

For external use only. Flammable keep away from fire or flame

Do not use

near eyes or mucous membranes
on deep or puncture wounds, animal bites or serious burns
over large areas of the body
more than one week unless directed by a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if condition persists or gets worse

Directions

clean affected area and spray 1 to 3 times daily
may be covered with a sterile bandage
children under 2 ask a doctor

Inactive Ingredients

isopropyl alcohol, purified water

Principal Display Panel – 2 fl. oz Packet Label

The Provision

First Aid

Line™

Antiseptic Spray

For Temporary Pain

Relief and to Help

Prevent Infection in

Minor Cuts, Scrapes

and Abrasions.

2 fl. oz. (59.1 ml)

Reorder no. 3501

Principal Display Panel – 2 fl. oz Packet Label

INGREDIENTS AND APPEARANCE

ANTISEPTIC

benzalkonium chloride, benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69103-5300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y)	benzalkonium chloride	1 g in 1 L
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)	benzocaine	46 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
isopropyl alcohol (UNII: ND2M416302)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69103-5300-0	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/25/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/25/2022

Labeler - Provision Medical (036936831)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(69103-5300)

Revised: 11/2013

Document Id: 7a4c6b17-2bb0-40e8-a855-4c88c7acae49

Set id: 0f6d3ee2-9106-43f9-957a-c1cce4c38ad1

Version: 1

Effective Time: 20131111