VAPORIZING CHEST RUB- menthol and camphor and eucalyptus oil gel 
Universal Distribution Center 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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Vaporising Chest Rub

Active Ingredients

Camphor            4.7%

Menthol             1.25%

Eucalyptus Oil   1.2%

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

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

VAPORISING CHEST RUB
NASAL DECONGESTANT AND COUGH SUPPRESSANT
NET WT.4 OZ (113g)

label

VAPORIZING CHEST RUB 
menthol and camphor and eucalyptus oil gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-039
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) MENTHOL1.25 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 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:52000-039-0850 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2018
2NDC:52000-039-0956.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2018
3NDC:52000-039-10100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2018
4NDC:52000-039-11113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2018
5NDC:52000-039-12150 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2018
6NDC:52000-039-13170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2018
7NDC:52000-039-14226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/14/2018
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-039)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-039)

Revised: 2/2022
Document Id: d8874472-8be1-38bc-e053-2995a90aaf3f
Set id: cfec7539-8db6-4bdf-9a6b-3416e9afc6d9
Version: 3
Effective Time: 20220221
 
Universal Distribution Center LLC