RUBBING ALCOHOL 70 PERCENT WITH WINTERGREEN- isopropyl alcohol liquid 
MY IMPORT USA INC

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 ingredient (BY VOLUME)

ISOPROPYL ALCOHOL (70% CONCENTRATE)

Purpose

FIRST AID ANTISEPTIC

Uses

FIRST AID TO HELP THE RISK OF INFECTION IN MINOR CUTS AND SCRAPES.

Keep Out of Reach of Children

IN CASE OF INGESTION, GET MEDICAL HELP OR CONTACT A POSON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.

WARNINGS

For external use only.

  • FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME
  • IF TAKEN NTERNALLY SERIOUS GASTRIC DISTURBANCES WILL RESULT

ASK A DOCTOR BEFORE USE IF YOU HAVE

  • DEEP OR PUNCTURE 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 USE AND ASK A DOCTOR IF

  • CONDITION PERSISTS OR GET WORSE.

Directions

  • CLEAN AFFECTED 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

Inactive Ingredient

BLUE 1, METHYL SALICYLATE, WATER, YELLOW 5

Amoray - 70pct Winter Green 51628-1003-1

RUBBING ALCOHOL  70 PERCENT WITH WINTERGREEN
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-1012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51628-1012-1355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/201405/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/03/201405/18/2018
Labeler - MY IMPORT USA INC (195767988)

Revised: 5/2018
Document Id: ab1b3b0b-639e-475e-a105-2429772e9d06
Set id: 2bbcda26-4796-4eee-9d75-0417cb76bb34
Version: 4
Effective Time: 20180518
 
MY IMPORT USA INC