CHEST RUB VAPORIZING- menthol and camphor and eucalyptus oil gel 
North & South Wholesalers LLC

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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Chest Rub Vaporizing

Active Ingredients

Camphor            4.7%

Menthol             1.0%

Eucalyptus Oil   1.0%

Purpose

Decongestant

Uses

Warnings

For external use only, avoid contact with eyes.

Do not use

Ask doctor before use 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:

adults and children 2 years and over:

do not use on children under 2 years unless directed by doctor

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

CHEST RUB VAPORIZING GEL

NASAL DECONGESTANT

COUGH SUPPRESSANT

NET WT. 4 OZ (113g)

label

CHEST RUB VAPORIZING 
menthol and camphor and eucalyptus oil gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70201-004
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:70201-004-09113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/03/2015
Labeler - North & South Wholesalers LLC (004948495)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(70201-004)

Revised: 11/2015
Document Id: 23b91af3-afd1-53dd-e054-00144ff8d46c
Set id: 51d5e0eb-dd71-450a-bb14-efbdfc6f5218
Version: 1
Effective Time: 20151104
 
North & South Wholesalers LLC