Label: STRONG VAPORIZING- chest rub, cold rub, nasal decongestant, cough suppressant, ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 72004-001-04 - Packager: AFN BROKER 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 January 10, 2019
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DRUG FACTS
ACTIVE INGREDIENTS
CAMPHOR 5.25%..............................COUGH SUPPRESSANT & TOPICAL ANALGESIC
EUCALYPTUS OIL 1.6%................................COUGH SUPPRESSANT
MENTHOL, NATURAL 3.15%..............................COUGH SUPPRESSANT & TOPICAL ANALGESIC
ASK A DOCTOR BEFORE USE IF YOU HAVE
*COUGH THAT OCCURS WITH TOO MUCH PHLEGM (MUCUS)* PERSISTENT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA, EMPHYSEMA
KEEP OUT OF REACH OF CHILDREN
IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY
USE
*ON CHEST & THROAT, TEMPORARILY RELIEVES COUGH DUE TO COMMON COLD
*ON MUSCLES & JOINTS, TEMPORARILY RELIEVES MINOR ACHES AND PAIN
WHEN USING THIS PRODUCT, DO NOT
*HEAT OR MICROWAVE
*ADD TO HOT WATER OR ANY CONTAINER WHERE HEATING WATER
MAY CAUSE SPLATTERING AND RESULTS IN BURNS
STOP USE AND ASK A DOCTOR IF
*MUSCLE ACHES AND PAINS PERSIST MORE THAN 7 DAYS OR COME BACK
*COUGH LASTS MORE THAN 7 DAYS, COME BACK, OR OCCURS IWTH FEVER RASH OR PERSISTENT HEADACHE.
THESE COULD BE SIGNS OF A SERIOUS CONDITION
DIRECTIONS
SEE IMPORTANT WARMING UNDER "WHEN USING THIS PRODUCT"
*ADULTS AND CHILDREN 2 YEARS AND OVER
*RUB A THICK LAYER ON CHEST & THROAT OR RUB ON SORE ACHING MUSCLES
*COVER WITH A WARM DRY CLOTH IF DESIRED
*KEEP CLOTHING LOOSE ABOUT THROAT/CHEST TO HELP VAPORS REACH NOSE/MOUTH
*REPEAT UP TO THREE TIMES PER 24 HOUSES OR AS DIRECTED BY A DOCTOR
*CHILDREN UNDER 2 YEARS OF AGE: ASK A DOCTOR
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INGREDIENTS AND APPEARANCE
STRONG VAPORIZING
chest rub, cold rub, nasal decongestant, cough suppressant, ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72004-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1.6 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.15 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5.25 g in 100 g Inactive Ingredients Ingredient Name Strength NUTMEG OIL (UNII: Z1CLM48948) 0.006 g in 100 g TURPENTINE OIL (UNII: C5H0QJ6V7F) THYMOL (UNII: 3J50XA376E) 0.001 g in 100 g PARAFFIN (UNII: I9O0E3H2ZE) 0.14 g in 100 g MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 0.05 g in 100 g Product Characteristics Color Score Shape Size 150mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72004-001-04 113 g in 1 JAR; Type 0: Not a Combination Product 07/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2018 Labeler - AFN BROKER LLC. (030117252)
*BY MOUTH
FOR EXTERNAL USE ONLY; AVOID CONTACT WITH EYES
ASK A HEALTH PROFESSIONAL BEFORE USE
STORE AT ROOM TEMPERATURE
NUTMEG OIL, TURPENTINE OIL, THYMOL, PARRAFIN WAX, MICROCRYSTALLINE WAX