VAPOUR RUB- camphor, eucalyptus, menthol ointment

VAPOUR RUB by

Drug Labeling and Warnings

VAPOUR RUB by is a Otc medication manufactured, distributed, or labeled by OPMX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

VAPOUR RUB 
camphor, eucalyptus, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 OIL	1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CEDAR LEAF OIL (UNII: BJ169U4NLG)
NUTMEG OIL (UNII: Z1CLM48948)
PETROLATUM (UNII: 4T6H12BN9U)
TURPENTINE OIL (UNII: C5H0QJ6V7F)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-101-11	1 in 1 BOX	07/16/2018
1		100 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 69729-101-12	1 in 1 BOX	07/16/2018
2		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/16/2018

Labeler - OPMX LLC (029918743)