Active Ingredients
CAMPHOR 4.8%
EUCALYPTUS 1.2%
MENTHOL 2.6%
Vapour Rub
FDA Label NDC 69729-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Vapour Rub (NDC 69729-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children., directions - see important warnings under "when using this product", other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- COUGH THAT OCCURS WITH TOO MUCH PHLEGM (MUCUS)
- PERSISTANT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA OR EMPHYSEMA
- HEAT
- MICROWAVE
- ADD TO HOT WATER OR ANY CONTAINER WHERE HEATING WATER. MAY CAUSE SPLATTERING AND RESULT IN BURNS.
- 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.
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"
- 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
Package Label.Principal Display Panel
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