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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Active ingredients

Camphor            4.7%

Menthol             1.25%

Eucalyptus Oil     1.2%

Purpose

Cough suppressant/topical analgesic

Cough suppressant/topical analgesic

Cough suppressant

Uses

Temporarily relieves throat and chest

Warnings

For external use only. Avoid contact with eyes.

Do not use

Ask a doctor before use if you have

When using this product do not

Stop use and ask a doctor if

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.

Directions

Other information

Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

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:33992-7991
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
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:33992-7991-4113 g in 1 JAR; Type 0: Not a Combination Product06/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/26/2018
Labeler - Greenbrier International, Inc. (610322518)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(33992-7991)

Revised: 1/2019
Document Id: 7fcfde78-2299-63a0-e053-2991aa0a0cf3
Set id: c7cdbf2f-4841-4a7a-9056-6a741abc3133
Version: 2
Effective Time: 20190119
 
Greenbrier International, Inc.