VAPOUR RUB- camphor, eucalyptus, menthol ointment 
OPMX 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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VAPOUR RUB

Active Ingredients

CAMPHOR 4.8%

EUCALYPTUS 1.2%

MENTHOL 2.6%

Purpose

COUPH SUPPRESSANT & TOPICAL ANALGESIC

COUGH SUPPRESSANT

COUPH SUPPRESSANT & TOPICAL ANALGESIC

Uses

Warnings

FOR EXTERNAL USE ONLY; AVOID CONTACT WITH EYES.

DO NOT USE

ASK A DOCTOR BEFORE USE IF YOU HAVE

WHEN USING THIS PRODUCT, DO OT

STOP USE AND ASK A DOCTOR IF

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"

Other information

Inactive ingredients

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

Vapour Rub - 50g

Vapour Rub - 100G new size

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)

Revised: 7/2018
Document Id: 321d70d2-4885-447d-bf73-d40f9db0fbd5
Set id: cbdbbc12-431f-4790-a1ce-d07fa7b16252
Version: 1
Effective Time: 20180716
 
OPMX LLC