ISOPROPYL RUBBING ALCOHOL 99%- isopropyl alcohol liquid

Isopropyl Rubbing Alcohol 99% by

Drug Labeling and Warnings

Isopropyl Rubbing Alcohol 99% by is a Otc medication manufactured, distributed, or labeled by First Aid Research Corp., Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (by volume)

Isopropyl Alcohol (99%)

PURPOSE

Purpose

First Aid Antiseptic

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

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

ASK DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds, animal bites or serious burns

WHEN USING

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

STOP USE

Stop use and ask a doctor if

• condition persists or gets worse

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Inactive Ingredient

Purified Water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 99%
FIRST AID ANTISEPTIC
12 FL.OZ (355 mL)

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL 99% 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75983-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	99 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75983-007-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2020
2	NDC: 75983-007-02	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2020
3	NDC: 75983-007-03	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2020
4	NDC: 75983-007-04	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2020
5	NDC: 75983-007-05	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2020
6	NDC: 75983-007-06	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2020
7	NDC: 75983-007-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020

Labeler - First Aid Research Corp. (089405927)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(75983-007)