ASSURED VAPORIZING CHEST RUB- camphor and eucalyptus oil and menthol ointment

Assured Vaporizing Chest Rub by

Drug Labeling and Warnings

Assured Vaporizing Chest Rub by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Camphor            4.7%

Eucalyptus Oil    1.0%

Menthol             1.0%

PURPOSE

Purpose

Cough Suppressant and Topical analgesic

Cough Suppressant

Cough Suppressant and Topical Analgesic

INDICATIONS & USAGE

Uses:

• Use on chest and throat to temporarily relieve cough
• Use on aching muscles to temporarily relieve minor aches and pains

WARNINGS

Warnings

For external use only; Do not take by mouth or place in nostrils. Avoid excessive heat. Never expose this product to flame or place in any container in which you are heating water. Never place in microwave oven.

ASK DOCTOR

Consult a doctor and discontinue use;

If cough persist for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Centre immediately.

DOSAGE & ADMINISTRATION

Directions:

Adults and children over 2 years of age; Rub a thick layer on chest and throat to provide temporary relief from nasal congestion and coughing due to colds. If desired, cover with dry, warm cloth, but keep clothing loose to let the vapours rise to nose and mouth. Repeat up to three times daily, especially at bedtime, or as directed by a doctor. Children under two years of age, consult a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Petrolatum, Mineral Oil, Nutmeg Oil, Spirits of Turpentine, Cedarleaf Oil, Thymol

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

INGREDIENTS AND APPEARANCE

ASSURED VAPORIZING CHEST RUB 
camphor and eucalyptus oil and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-7996
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.7 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-7996-4	113 g in 1 JAR; Type 0: Not a Combination Product	11/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/20/2015

Labeler - Greenbrier International, Inc. (610322518)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(33992-7996)