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NDC 69103-5500-00 Isopropyl Alcohol 700 mL/L Details

Isopropyl Alcohol 700 mL/L

Isopropyl Alcohol is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Provision Medical. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	69103-5500
Product ID	69103-5500_fbcd061b-5cb1-4afe-b316-9b08e786834c
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	Isopropyl Alcohol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	700
Active Ingredient Units	mL/L
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Provision Medical
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 69103-5500-00 (69103550000)

Pricing Information	N/A
NDC Package Code	69103-5500-0
Billing NDC	69103550000
Package	.0591 L in 1 BOTTLE, SPRAY (69103-5500-0)
Marketing Start Date	2022-07-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ad045374-f4ad-4003-b350-8a2b0cbccb2e Details

Active Ingredients

Isopropyl Alcohol 70%

Purpose

First Aid Antiseptic

Uses

First aid to help prevent infection 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

Keep out of reach of children

Caution

not for use on large areas of the body
if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician.

Directions

spray over cleaned affected area 1 to 3 times daily

Inactive Ingredients

purified water

Principal Display Panel – 2 fl. oz Bottle Label

The Provision

First Aid

Line™

Isopropyl

Alcohol Spray

First Aid to Help

Prevent Infection in

Minor Cuts, Scrapes

and Burns.

2 fl. oz. (59.1 ml)

Reorder no. 3502

Principal Display Panel – 2 fl. oz Bottle Label

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL

isopropyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69103-5500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302)	isopropyl alcohol	700 mL in 1 L

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69103-5500-0	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(69103-5500)

Revised: 11/2013

Document Id: fbcd061b-5cb1-4afe-b316-9b08e786834c

Set id: ad045374-f4ad-4003-b350-8a2b0cbccb2e

Version: 1

Effective Time: 20131111