Your browser does not support JavaScript! ISOPROPYL WINTER GREEN RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [WORLDWIDE SALES & DISTRIBUTION CORP.]
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ISOPROPYL WINTER GREEN RUBBING ALCOHOL (isopropyl alcohol) liquid
[Worldwide Sales & Distribution Corp.]


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

Drug Facts

Active Ingredients


Isopropyl Alcohol 50%

Purpose


First aid antiseptic

Uses

First aid to help prevent risk of infection in

  • scrap
  • burns
  • minor cuts

Warnings

For external use only

  • Flammable keep away from fire and flames

Consult a doctor before use if you have animal bites or serious burns, deep or punctured wounds

When using this product

  • do not let it get into your eyes
  • do not apply over large areas of the body
  • do not use longer than a week unless directed by the doctor
  • do not use other than as directed

Stop use and ask a doctor if condition persists or worsens

Keep out of reach of children. In case of an accidental ingestion, seek professional assistance or contact a poison control center immediately.

Directions


  • clean affected area
  • apply a small amount of this product on the affected area 1-3 times a day
  • may be covered with a sterile bandage but let dry before using bandage

Other information


  • Store at controlled room temperature
  • Not intended as substitute for grain or ethyl alcohol
  • Will produce serious gastric disturbance if taken internally

Inactive ingredient

Green 3, Yellow 5, Methyl salicylate, Purified water

Package Label

Container Label

ISOPROPYL WINTER GREEN RUBBING ALCOHOL  
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76384-006
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
WATER50 mL  in 100 mL
FD&C BLUE NO. 1 
METHYL SALICYLATE 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76384-006-01355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/15/2011
Labeler - Worldwide Sales & Distribution Corp. (627014330)
Establishment
NameAddressID/FEIBusiness Operations
Steller Mercantile Pvt. Ltd.650493005manufacture

Revised: 8/2011
 
Worldwide Sales & Distribution Corp.

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