OTC Medication Information: U 99% ISOPROPYL RUBBING ALCOHOL

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.

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

  • 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 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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 99 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73003-007-01 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:73003-007-02 177 mL in 1 BOTTLE, PLASTIC None
3 NDC:73003-007-03 237 mL in 1 BOTTLE, PLASTIC None
4 NDC:73003-007-04 296 mL in 1 BOTTLE, PLASTIC None
5 NDC:73003-007-05 355 mL in 1 BOTTLE, PLASTIC None
6 NDC:73003-007-06 414 mL in 1 BOTTLE, PLASTIC None
7 NDC:73003-007-07 473 mL in 1 BOTTLE, PLASTIC None
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 Operations
BIOTEK INDIA 675484458 manufacture (73003-007)

Revised: 09/2020 BIOTEK INDIA

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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