Label: VAPOUR RUB- camphor, eucalyptus, menthol ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69729-101-11, 69729-101-12 - Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 16, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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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.
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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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VAPOUR RUB
camphor, eucalyptus, menthol ointmentProduct 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)
