U 99% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid

U 99% ISOPROPYL RUBBING ALCOHOL by

Drug Labeling and Warnings

U 99% ISOPROPYL RUBBING ALCOHOL by is a Otc medication manufactured, distributed, or labeled by BIOTEK INDIA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (by volume):

Isopropyl alcohol (99% conc.)

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 or flame, heat, spark, electrical

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 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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

Inactive Ingredient Purified Water

SPL UNCLASSIFIED SECTION

FIRST AID ANTISEPTIC

For Rubbing & Massaging

Use only in a well ventilated area;

Fumes may be harmful.

WARNINGS FLAMMABLE!

Keep away from fire or flame!

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

Made in India

Distributed by: Universal Distribution Center

96 Distribution Boulevard Edison, NJ 08817

Packaging

INGREDIENTS AND APPEARANCE

U 99% ISOPROPYL RUBBING ALCOHOL 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73003-007
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: 73003-007-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2020
2	NDC: 73003-007-02	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2020
3	NDC: 73003-007-03	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2020
4	NDC: 73003-007-04	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2020
5	NDC: 73003-007-05	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2020
6	NDC: 73003-007-06	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2020
7	NDC: 73003-007-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/20/2020

Labeler - BIOTEK INDIA (675484458)

Establishment
Name	Address	ID/FEI	Business Operations
BIOTEK INDIA		675484458	manufacture(73003-007)