91% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid

91% Isopropyl Rubbing Alcohol by

Drug Labeling and Warnings

91% Isopropyl Rubbing Alcohol by is a Otc medication manufactured, distributed, or labeled by MY IMPORTS USA LLC, Jell Pharmaceuticals Pvt Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (by volume):

Isopropyl alcohol

(91% 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, etc.

Ask a doctor before use if you have

Deep punctured wounds, animal bites or serious burns

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

Stop using this product if

Condition persists or gets worse

Keep this drug out of the reach of children

In case of an accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1222) immediately

Directions

Clean effected area

Apply small amount of this product on the area 1-3 times daily

May be covered with a sterile bandage

If bandaged, let dry first

Other information

Store at room temperature

Does not contain, nor is intended as a substitute for grain or ethyl alcohol. Will produce serious gastric disturbances if taken internally

Inactive Ingredient

Water(Aqua)

SPL UNCLASSIFIED SECTION

AS 9175

Use only in a well ventilated area

Fumes may be harmful

WARNING FLAMMABLE

keep away from fire or flame!

91% by volume

TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP SAFETY FOIL IS BROKEN OR MISSING

Made in India

Packaging

INGREDIENTS AND APPEARANCE

91% ISOPROPYL RUBBING ALCOHOL 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51628-4236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	91 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: 51628-4236-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021
2	NDC: 51628-4236-2	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021
3	NDC: 51628-4236-3	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/14/2021

Labeler - MY IMPORTS USA LLC (195767988)

Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt Ltd.		726025211	manufacture(51628-4236)