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NDC 72976-0001-01 70% Isopropyl Rubbing Alcohol 70 mL/100mL Details

70% Isopropyl Rubbing Alcohol 70 mL/100mL

70% Isopropyl Rubbing Alcohol is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by SZY Holdings, LLC dba EverReady First Aid. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	72976-0001
Product ID	72976-001_a8232f85-74b8-09e0-e053-2a95a90abe1e
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	70% Isopropyl Rubbing Alcohol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	SZY Holdings, LLC dba EverReady First Aid
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 72976-0001-01 (72976000101)

Pricing Information	N/A
NDC Package Code	72976-001-01
Billing NDC	72976000101
Package	118 mL in 1 BOTTLE, PLASTIC (72976-001-01)
Marketing Start Date	2020-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1e39b0f4-66d1-47ac-aed6-d6ac019888ce Details

SPL UNCLASSIFIED SECTION

Active Ingredient (by volume)

Isopropyl Alcohol (70%)

SPL UNCLASSIFIED SECTION

Purpose

First Aid Antiseptic

SPL UNCLASSIFIED SECTION

Uses

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

SPL UNCLASSIFIED SECTION

Warnings

For external use only

Flammable, keep away from fire and flame
if taken internally, serious gastric disturbances will result

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

SPL UNCLASSIFIED SECTION

When using this product

do not get into eyes
do not apply over large areas of the body
do not use longer than one week unless directed by a doctor
do not use otherwise than directed

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

condition persists or gets worse

SPL UNCLASSIFIED SECTION

Keep out of reach of children

In case of ingestion, get medical help or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Directions

clean effected area
apply a small amount of this product on the area 1 to 3 times daily
if bandaged, let dry first
may be covered with a sterile bandage

SPL UNCLASSIFIED SECTION

Other information

store at room temperature
does not contain, nor is intended as a substitute for grain or ethyl alcohol

SPL UNCLASSIFIED SECTION

Inactive Ingredient

Purified Water

PRINCIPAL DISPLAY PANEL

70% ISOPROPYL RUBBING ALCOHOL

FIRST AID ANTISEPTIC

16 FL.OZ (473 mL)

INGREDIENTS AND APPEARANCE

70% ISOPROPYL RUBBING ALCOHOL

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72976-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72976-001-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020
2	NDC:72976-001-02	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020
3	NDC:72976-001-03	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020
4	NDC:72976-001-04	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020
5	NDC:72976-001-05	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020
6	NDC:72976-001-06	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020
7	NDC:72976-001-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/15/2020

Labeler - SZY Holdings, LLC dba EverReady First Aid (147372960)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(72976-001)

Revised: 6/2020

Document Id: a8232f85-74b8-09e0-e053-2a95a90abe1e

Set id: 1e39b0f4-66d1-47ac-aed6-d6ac019888ce

Version: 1

Effective Time: 20200615

Search by Drug Name or NDC

NDC 72976-0001-01 70% Isopropyl Rubbing Alcohol 70 mL/100mL Details

70% Isopropyl Rubbing Alcohol 70 mL/100mL

Product Information

Package

Package Images

NDC 72976-0001-01 (72976000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1e39b0f4-66d1-47ac-aed6-d6ac019888ce Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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