VAPORISING CHEST RUB- camphor, menthol, eucalyptus oil cream 
New Pride Corp

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        Purpose

Menthol 2.6%             Cough supressant/Topical Analgesic

Camphor 4.8%            Cough supressant/Topical Analgesic

Eucalyptus oil 1.2%      Cough Supressant

Uses   Temporarily relieves throat and chest

- cough

- nasal congestion due to common cold

- aching muscles

- minor aches and pains

Keep out of reach of children. In case of of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop use and ask a doctor if

muscle aches/pains persist for more than 7 days or come back

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. Thes could be signs of a serious condition

Warnings

For external use only

Do not use

- by mouth

- in nostrils

- on wounds or damaged skin

- with light bandages

Ask a doctor before use if you have

- asthma

- excessive phlegm (mucus)

- emphysema

- persistant or chronic cough

- cough associated with smoking

When using this product do not

- heat

- microwave

- use near open flame

- add to hot water or any container where heating water may cause splattering and result in burns

If pregnant or breat feeding, ask a health professional before use

Directions

- see important warnings under "When Using this product"

- children under 2 years of age, ask a doctor before using the product

- Adults and children 2 years and older. rub a thick layer of on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily

Other information Store at room temperature

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

Vaporising chest rub

Label

VAPORISING CHEST RUB 
camphor, menthol, eucalyptus oil cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58037-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.8 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 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)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
THYMOL (UNII: 3J50XA376E)  
TURPENTINE (UNII: XJ6RUH0O4G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58037-010-01113 g in 1 JAR; Type 0: Not a Combination Product02/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/14/2022
Labeler - New Pride Corp (884264198)
Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt Ltd.726025211manufacture(58037-010)

Revised: 3/2023
Document Id: f6647680-5702-0580-e053-2995a90a2629
Set id: f66476d5-036b-0b1c-e053-2a95a90a0a07
Version: 1
Effective Time: 20230308
 
New Pride Corp