Your browser does not support JavaScript! ISOPROPYL RUBBING ALCOHOL 50% (ISOPROPYL ALCOHOL) LIQUID [ UNIVERSAL DISTRIBUTION CENTER LLC]
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RxNorm Names

ISOPROPYL RUBBING ALCOHOL 50% (isopropyl alcohol) liquid
[ Universal Distribution Center LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredients (by volume)

Isopropyl alcohol (50% 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 disturbance if taken internally

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
 
Universal Distribution Center LLC

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