4OZ MEDICATED CHEST RUB- menthol, camphor, eucalyptus oil ointment 
Pride Products Corporation

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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ACTIVE INGREDIENTS

Active Ingredients Purpose

Menthol 1.0% Decongestant

camphor 4.7% Decongestant

Eucalyptus Oil 1.0 % Decongestant

Purpose

Decongestant

USE:

To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.

Warnings:

For external use only. Not for internal use. Avoil contact with eyes. Do not put in mouth, nostrils or on wounds or damaged skin.

If pregnant or breast feeding,

consult a physician before use.

Do not use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.

Consult a physician before use.

If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus. If muscle aches persist for more than 7 days or comes back or if cough lasts more than 7 days, come back or occurs with fever, rash or a persistent headache.

Keep out of reach of children.

If ingested, get medical help or contact a Posion Control Center right away.

Directions:

Adults and children 2 years of age and older rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles. If desired, loosely cover with a soft dry cloth but keep clothing loose. Repeat up to three times daily, especially at bedtime. children under 2 years of age, consult your physician.

Inactive Ingredients:

Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil.

label

4OZ MEDICATED CHEST RUB 
menthol, camphor, eucalyptus oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81984-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
NUTMEG OIL (UNII: Z1CLM48948)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
THYMOL (UNII: 3J50XA376E)  
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81984-099-01110 g in 1 JAR; Type 0: Not a Combination Product12/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2017
Labeler - Pride Products Corporation (112666285)
Registrant - Pride Products Corporation (112666285)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(81984-099)

Revised: 12/2017
Document Id: 60c0bc37-83b2-3280-e053-2a91aa0ae7c9
Set id: 60c0bc37-83b1-3280-e053-2a91aa0ae7c9
Version: 1
Effective Time: 20171220
 
Pride Products Corporation