VAPOUR RUB (CAMPHOR, EUCALYPTUS, MENTHOL) OINTMENT [OPMX LLC]

VAPOUR RUB (CAMPHOR, EUCALYPTUS, MENTHOL) OINTMENT [OPMX LLC]
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NDC 69729-101-11, 69729-101-12
Set ID cbdbbc12-431f-4790-a1ce-d07fa7b16252
Category HUMAN OTC DRUG LABEL
Packager OPMX LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredients

    CAMPHOR 4.8%

    EUCALYPTUS 1.2%

    MENTHOL 2.6%

  • Purpose

    COUPH SUPPRESSANT & TOPICAL ANALGESIC

    COUGH SUPPRESSANT

    COUPH SUPPRESSANT & TOPICAL ANALGESIC

  • Uses

    • ON CHEST & THROAT, TEMPORARILY RELIEVES COUGH DUE TO MINOR THROAT AND BRONCHIAL IRRITATION ASSOCIATED WITH THE COMMON COLD
    • WHEN APPLIED TO MUSCLES AND JOINTS, TEMPORARILY RELIEVES MINOR ACHES AND PAINS OF MUSCLES AND JOINTS

  • Warnings

    FOR EXTERNAL USE ONLY; AVOID CONTACT WITH EYES.

    DO NOT USE

    • BY MOUTH
    • IN NOSTRILS
    • ON WOUNDS OR DAMAGED SKIN
    • WITH TIGHT BANDAGES

    ASK A DOCTOR BEFORE USE IF YOU HAVE

    • COUGH THAT OCCURS WITH TOO MUCH PHLEGM (MUCUS)
    • PERSISTANT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA OR EMPHYSEMA

    WHEN USING THIS PRODUCT, DO OT

    • HEAT
    • MICROWAVE
    • ADD TO HOT WATER OR ANY CONTAINER WHERE HEATING WATER. MAY CAUSE SPLATTERING AND RESULT IN BURNS.

    STOP USE AND ASK A DOCTOR IF

    • MUSCLE ACHES AND PAINS WORSEN OR PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS
    • COUGH PERSISTS FOR MORE THAN 1 WEEK, TENDS TO RECUR, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT COUGH MAY BE A SIGN OF A SERIOUS CONDITION.

    IF PREGNANT OR BRAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS - SEE IMPORTANT WARNINGS UNDER "WHEN USING THIS PRODUCT"

    • ADULTS AND CHILDREN 2 YEARS AND OVER:
    • FOR COUGH SUPPRESSION
    • RUB A THICK LAYER ON THROAT & CHEST
    • COVER WITH A WARM, DRY CLOTH IF DESIRED
    • KEEP CLOTHING LOOSE ABOUT THROAT AND CHEST TO HELP VAPORS REACH THE NOSE AND MOUTH
    • USE UP TO THREE TIMES DAILY OR AS DIRECTED BY A DOCTOR
    • FOR MUSCLE/JOINT MINOR ACHES AND PAINS APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY
    • CHILDREN UNDER 2 YEARS DO NOT USE
  • Other information

    • STORE AT ROOM TEMPERATURE

  • Inactive ingredients

    CEDARLEAF OIL, NUTMEG OIL, PETROLATUM, SPIRITS OF TURPENTINE, THYMOL

  • PRINCIPAL DISPLAY PANEL

    Vapour Rub - 50g

    Vapour Rub - 100G new size

  • INGREDIENTS AND APPEARANCE
    VAPOUR RUB 
    camphor, eucalyptus, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.8 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-101-111 in 1 BOX07/16/2018
    1100 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:69729-101-121 in 1 BOX07/16/2018
    250 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/16/2018
    Labeler - OPMX LLC (029918743)

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