HEALTH SMART VAPORIZING CHEST RUB- menthol and camphor and eucalyptus oil gel 
Jell Pharmaceuticals Pvt Ltd.

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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medicated chest rub

Active Ingredients

Camphor            4.7%

Menthol             1.0%

Eucalyptus Oil   1.0%

Purpose

Cough Suppressant

Topical Analgesic

Nasal Decongestant

Uses

Warnings

For external use only. Avoid contact with eyes.

Do not take by mouth or place in nostrils.

Do not use

Ask doctor if you have,

When using this product, do not

Stop use and ask a doctor if:

Keep out of the reach of children

If ingested get medical help or contact a Poison control center immediately

Directions: see important warnings under “When using this product”

adults and children 2 years and over:

children under 2 years of age: ask a doctor

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

HEALTH SMART VAPORISING CHEST RUB GEL

DECONGESTANT AND COUGH SUPPRESSANT

NET WT.4 OZ (113g)

Label

HEALTH SMART VAPORIZING CHEST RUB 
menthol and camphor and eucalyptus oil gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-702
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:30400-702-0150 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
2NDC:30400-702-0256.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
3NDC:30400-702-03100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2022
Labeler - Jell Pharmaceuticals Pvt Ltd. (726025211)
Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(30400-702)

Revised: 2/2022
Document Id: d80cada1-5c90-8e38-e053-2995a90a89ac
Set id: d80cad8d-da4c-049d-e053-2a95a90ac20e
Version: 1
Effective Time: 20220215
 
Jell Pharmaceuticals Pvt Ltd.