STRONG VAPORIZING- chest rub, cold rub, nasal decongestant, cough suppressant, ointment 
AFN BROKER 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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DRUG FACTS

Drug Fact

ACTIVE INGREDIENTS

CAMPHOR 5.25%..............................COUGH SUPPRESSANT & TOPICAL ANALGESIC

EUCALYPTUS OIL 1.6%................................COUGH SUPPRESSANT

MENTHOL, NATURAL 3.15%..............................COUGH SUPPRESSANT & TOPICAL ANALGESIC Active Ingredients

DO NOT USE

DO NOT USE*BY MOUTH

*WITH TIGHT BANDAGES

*IN NOSTRILS

*ON WOUNDS OR DAMAGED SKIN

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR*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

KEEP OUT OF REACH OF CHILDRENIN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

WARNINGS

WARNINGSFOR EXTERNAL USE ONLY; AVOID CONTACT WITH EYES

IF PREGNANT OR BREAST-FEEDING

PREGNANTASK A HEALTH PROFESSIONAL BEFORE USE

USE

USES*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

WHEN USING*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

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

STORAGE

STORAGESTORE AT ROOM TEMPERATURE

DIRECTIONS

DIRECTIONSSEE 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

INACTIVE INGREDIENTS

INACTIVE INGREDIENTSNUTMEG OIL, TURPENTINE OIL, THYMOL, PARRAFIN WAX, MICROCRYSTALLINE WAX

PURPOSE

COUGH SUPPRESSANT & TOPICAL ANALGESIC PURPOSE

Directions

USE

STRONG VAPORIZING 
chest rub, cold rub, nasal decongestant, cough suppressant, ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72004-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.6 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.15 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize150mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72004-001-04113 g in 1 JAR; Type 0: Not a Combination Product07/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2018
Labeler - AFN BROKER LLC. (030117252)

Revised: 1/2019
Document Id: 7f1e9bdf-cd90-272f-e053-2a91aa0aabf4
Set id: 67791380-e5d0-cbbf-e053-2a91aa0a6f69
Version: 4
Effective Time: 20190110
 
AFN BROKER LLC.