Chest Rub and Cough Suppressant

Chest Rub and Cough Suppressant by

Drug Labeling and Warnings

Chest Rub and Cough Suppressant by is a Otc medication manufactured, distributed, or labeled by ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHEST RUB AND COUGH SUPPRESSANT- menthol and camphor and eucalyptus oil gel 
ANICARE PHARMACEUTICALS PRIVATE LIMITED

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 and Cough Suppressant

Active Ingredients

Menthol 2.0%

Camphor 4.7%

Eucalyptus Oil 1.0%

Purpose

Decongestant

USE:

To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.

Warnings:

For external use only. Not for internal use. Avoid contact with eyes. Do not put in mouth, nostrils or on wounds or damaged skin.

If pregnant or breast feeding: Consult a physician before use.

Do not

use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.

Keep out of reach of children:

If ingested get medical help or contact a Poison Control Center right away.

Consult a physician before use:

If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus. If muscle aches persist for more than 7 days or comes back or if cough lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache.

Directions:

Adults and children 2 years of age and older rub thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles. if desired, loosely cover with a soft dry cloth but keep clothing loose. Repeat up to three times daily, especially at bedtime. Children under 2 years of age, consult your physician.

Inactive Ingredients:

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

CHEST RUB AND COUGH SUPPRESSANT 
menthol and camphor and eucalyptus oil gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47046-991
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5.31 g  in 113 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.26 g  in 113 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.13 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
NUTMEG OIL (UNII: Z1CLM48948)
TURPENTINE (UNII: XJ6RUH0O4G)
THYMOL (UNII: 3J50XA376E)
CEDAR LEAF OIL (UNII: BJ169U4NLG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47046-991-14	113 g in 1 JAR; Type 0: Not a Combination Product	01/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/29/2021

Labeler - ANICARE PHARMACEUTICALS PRIVATE LIMITED (916837425)

Revised: 1/2021

Document Id: 1a0c4b00-a390-4d56-b4c5-f94851f01fc9

34390-5

Set id: a843ad18-e453-495d-81ba-ab46f200e9b0

Version: 1

Effective Time: 20210129