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NDC 00168-0907-60 Isopropyl Alcohol 75 mL/60mL Details

Isopropyl Alcohol 75 mL/60mL

Isopropyl Alcohol is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	00168-0907
Product ID	0168-0907_288add98-f2b9-44ba-9992-0cbc77bf7328
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	SOLUTION
Route	TOPICAL
Active Ingredient Strength	75
Active Ingredient Units	mL/60mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Fougera Pharmaceuticals Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00168-0907-60 (00168090760)

Pricing Information	N/A
NDC Package Code	0168-0907-60
Billing NDC	00168090760
Package	60 mL in 1 BOTTLE (0168-0907-60)
Marketing Start Date	2020-05-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 288add98-f2b9-44ba-9992-0cbc77bf7328 Details

Drug Facts

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only USP grade ingredients in the preparation of the product, consistent with World Health Organization (WHO) recommendations.

The firm does not add other active or inactive ingredients.

Active ingredient(s)

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do Not Use

▪: in children less than 2 months of age
▪: on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out of Reach of Children

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

Directions

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

▪: Store between 15° to 30°C (59° to 86°F)
▪: Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP.

Package/Label Principal Display Panel - 60mL Bottle

NDC 0168-0907-60

E.FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Isopropyl Alcohol Antiseptic 75% Topical Solution

Hand Sanitizer

Non-sterile Solution

60 mL

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL

isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0168-0907
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 60 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0168-0907-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/15/2020

Labeler - Fougera Pharmaceuticals Inc. (043838424)

Name	Address	ID/FEI	Business Operations
Establishment
Fougera Pharmaceuticals Inc.		174491316	MANUFACTURE(0168-0907)

Revised: 4/2020

Document Id: 288add98-f2b9-44ba-9992-0cbc77bf7328

Set id: 288add98-f2b9-44ba-9992-0cbc77bf7328

Version: 1

Effective Time: 20200428