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.

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Assured Vaporizing Chest Rub

Active Ingredients

Camphor            4.7%

Eucalyptus Oil    1.0%

Menthol             1.0%

Purpose

Cough Suppressant and Topical analgesic

Cough Suppressant

Cough Suppressant and 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:

Adults and children over 2 years of age; Rub a thick layer on chest and throat to provide temporary relief from nasal congestion and coughing due to colds. If desired, cover with dry, warm cloth, but keep clothing loose to let the vapours rise to nose and mouth. Repeat up to three times daily, especially at bedtime, or as directed by a doctor. Children under two years of age, consult a doctor.

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:33992-7996
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
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
Inactive Ingredients
Ingredient NameStrength
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
NUTMEG OIL (UNII: Z1CLM48948)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
THYMOL (UNII: 3J50XA376E)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-7996-4113 g in 1 JAR; Type 0: Not a Combination Product11/20/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/20/2015
Labeler - Greenbrier International, Inc. (610322518)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(33992-7996)

Revised: 8/2017
Document Id: 580f2345-12c0-5155-e053-2a91aa0ab013
Set id: 24fdad60-490d-6dc5-e054-00144ff8d46c
Version: 2
Effective Time: 20170831
 
Greenbrier International, Inc.