ASSURED VAPORIZING CHEST RUB- camphor and eucalyptus oil and menthol ointment 
Greenbrier International, Inc.

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.

----------

Active Ingredients

Camphor            4.7%

Eucalyptus Oil    1.2%

Menthol            1.25%

Purpose

Cough Suppressant & Topical analgesic

Cough Suppressant

Cough Suppressant & Topical analgesic

Uses

Warnings

For external use only; Do not take by mouth or place in nostrils. Avoid excessive heat. Never expose this product to flame or place in any container in which you are heating water. Never place in microwave oven.

Consult a doctor and discontinue use;

If cough persist for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Centre immediately.

Directions:

Inactive Ingredients:

Petrolatum, Mineral Oil, Nutmeg Oil, Spirits of Turpentine, Cedarleaf Oil, Thymol

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

label

ASSURED VAPORIZING CHEST RUB 
camphor and eucalyptus oil and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-7992
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.7 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
NUTMEG OIL (UNII: Z1CLM48948)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
THYMOL (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-7992-4113 g in 1 JAR; Type 0: Not a Combination Product01/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/18/2019
Labeler - Greenbrier International, Inc. (610322518)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(33992-7992)

Revised: 1/2019
Document Id: 7fcfde78-22a9-63a0-e053-2991aa0a0cf3
Set id: b8f0c61e-83b0-4835-b950-2c5dcce5cf17
Version: 1
Effective Time: 20190119
 
Greenbrier International, Inc.