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NDC 30400-0100-04 Isopropyl Rubbing Alcohol 50 mL/100mL Details

Isopropyl Rubbing Alcohol 50 mL/100mL

Isopropyl Rubbing Alcohol is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Jell Pharmaceuticals Pvt. Ltd.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	30400-0100
Product ID	30400-100_cd8643ef-dc84-8bc1-e053-2995a90a007b
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 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	50
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Jell Pharmaceuticals Pvt. Ltd.
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 30400-0100-04 (30400010004)

Pricing Information	N/A
NDC Package Code	30400-100-04
Billing NDC	30400010004
Package	946 mL in 1 BOTTLE, PLASTIC (30400-100-04)
Marketing Start Date	2012-06-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cd8643ef-dc83-8bc1-e053-2995a90a007b Details

Active Ingredients

Isopropyl alcohol (50% conc.)

Purpose

First aid antiseptic

Uses

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

Warnings

For external use only

flammable, keep away from fire or flame, heat, spark, electrical

Ask a doctor before use if you have

deep puncture wounds, animal bites or serious burns

When using this product

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

Stop using this product if

condition persists or gets worse

Keep this and all drugs out of the reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately

Directions

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

Inactive ingredient

purified water

Packaging

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30400-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	50 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30400-100-01	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
2	NDC:30400-100-02	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
3	NDC:30400-100-03	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
4	NDC:30400-100-04	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
5	NDC:30400-100-05	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/29/2012

Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt Ltd.		726025211	manufacture(30400-100)

Revised: 9/2021

Document Id: cd8643ef-dc84-8bc1-e053-2995a90a007b

Set id: cd8643ef-dc83-8bc1-e053-2995a90a007b

Version: 1

Effective Time: 20210927