ISOPROPYL RUBBING ALCOHOL 50%- isopropyl alcohol liquid 
Universal Distribution Center LLC

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.

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Active Ingredients (by volume)

Isopropyl alcohol (50% conc.)

Purpose

First aid antiseptic

Uses

Warnings

For external use only; flammable, keep away from fire or flame, heat, spark, electrical

Ask a doctor before use if you have

When using this product

Stop using this product if

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

Water(Aqua)

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50%

FIRST AID ANTISEPTIC

12 FL.OZ (355 mL)

label

ISOPROPYL RUBBING ALCOHOL 50% 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52000-008
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL50 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-008-01118 mL in 1 BOTTLE, PLASTIC
2NDC:52000-008-02177 mL in 1 BOTTLE, PLASTIC
3NDC:52000-008-03237 mL in 1 BOTTLE, PLASTIC
4NDC:52000-008-04296 mL in 1 BOTTLE, PLASTIC
5NDC:52000-008-05355 mL in 1 BOTTLE, PLASTIC
6NDC:52000-008-06414 mL in 1 BOTTLE, PLASTIC
7NDC:52000-008-07473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/13/2012
Labeler -  Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-008)

Revised: 3/2013
Document Id: 92adc7a8-fb36-4bca-806d-c1bb753e359d
Set id: 010a9d81-4039-441b-b478-41ccf527e4df
Version: 1
Effective Time: 20130313
 
Universal Distribution Center LLC