VAPORIZING RUB- camphor, eucalyptus oil and menthol ointment

Vaporizing Rub by

Drug Labeling and Warnings

Vaporizing Rub by is a Otc medication manufactured, distributed, or labeled by ALAINA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredient                                                                                              Purpose

Camphor (synthetic) 4.8% ....................................................................Cough suppressant & topical analgesic

Eucalyptus Oil 1.2% .............................................................................Cough suppressant

Menthol 2.6% .......................................................................................Cough suppressant & topical analgesic

PURPOSE

INDICATIONS & USAGE

Uses:

• temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
• temporarily relieves minor aches and pains of muscles and joints

WARNINGS

Warnings

For external use only; avoid contact with eyes.

Do not use

• by mouth
• in nostrils
• on wounds or damaged skin
• with tight bandages

ASK DOCTOR

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma or emphysema

When using this product, do not

• heat
• microwave
• add to hot water or any container where heating water.

May cause splattering and result in burns. Stop use and ask a doctor if

• muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days.
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,ask a healthcare professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions:

• see important warnings under "When using this product"
• adults and children 2 years and over:
• rub a thick layer on the throat and chest for cough, or rub on sore aching muscles or joints
• clothing should be left loose about the throat and chest to help vapors reach the nose and mouth
• use up to 3 times daily or as directed by doctor
• children under 2 years: do not use
• cover with a warm, dry cloth if desired

Other information

• store at room temperature

INACTIVE INGREDIENT

Inactive Ingredients

cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Vaporizing Rub

Camphor, Eucalyptus Oil, Menthol

Cough Suppressant

Topical Analgesic

Ointment

NET WT 1.76 OZ (50g)

INGREDIENTS AND APPEARANCE

VAPORIZING RUB 
camphor, eucalyptus oil and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73492-716
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2.4 g  in 50 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.3 g  in 50 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.6 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
CEDAR LEAF OIL (UNII: BJ169U4NLG)
NUTMEG OIL (UNII: Z1CLM48948)
PETROLATUM (UNII: 4T6H12BN9U)
THYMOL (UNII: 3J50XA376E)
TURPENTINE OIL (UNII: C5H0QJ6V7F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73492-716-50	1 in 1 CARTON	07/18/2023
1		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/18/2023

Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)

Establishment
Name	Address	ID/FEI	Business Operations
ALAINA HEALTHCARE PRIVATE LIMITED		858720927	manufacture(73492-716)