U 99% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid 
BIOTEK INDIA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

U 99% ISOPROPYL Rubbing Alcohol

Drug Facts

Active Ingredients (by volume):

Isopropyl alcohol (99% 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 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

Directions

Other information

Inactive Ingredient Purified Water

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

label

U 99% ISOPROPYL RUBBING ALCOHOL 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73003-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL99 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73003-007-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
2NDC:73003-007-02177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
3NDC:73003-007-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
4NDC:73003-007-04296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
5NDC:73003-007-05355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
6NDC:73003-007-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
7NDC:73003-007-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/20/2020
Labeler - BIOTEK INDIA (675484458)
Establishment
NameAddressID/FEIBusiness Operations
BIOTEK INDIA675484458manufacture(73003-007)

Revised: 9/2020
Document Id: b7882e9b-1369-44df-95c8-e9263c15f1bb
Set id: 6fe9bd2b-f344-4687-9db5-d7b98fb9e882
Version: 1
Effective Time: 20200903
 
BIOTEK INDIA