VAPORIZING CHEST RUB- menthol and camphor and eucalyptus oil gel

Vaporizing Chest Rub by

Drug Labeling and Warnings

Vaporizing Chest Rub by is a Otc medication manufactured, distributed, or labeled by FOUR SEASONS TRADING INC, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Camphor            4.7%

Menthol             1.0%

Eucalyptus Oil   1.0%

PURPOSE

Purpose

Cough Suppressant

Topical Analgesic

Nasal Decongestant

INDICATIONS & USAGE

Uses

• On chest and throat, helps temporarily relieve cough as may occur with common cold and minor bronchial irritation.
• For the temporary relief of pain associated with minor skin irritation.

WARNINGS

Warnings

For external use only. Avoid contact with eyes.

Do not take by mouth or place in nostrils.

DO NOT USE

Do not use

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

• with persistent or chronic cough such as occurs with asthma, emphysema or smoking

ASK DOCTOR

Ask doctor if you have,

• cough that occurs with too much phlegm (mucus)

WHEN USING

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

Stop use and ask a doctor if:

• cough  that lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

If ingested get medical help or contact a Poison control center immediately

DOSAGE & ADMINISTRATION

Directions: see important warnings under “When using this product”

adults and children 2 years and over:

• rub a thick layer on chest and throat
• keep clothing loose around chest/throat to help vapors reach the nose/mouth
• use up to 3 times daily as directed by doctor

children under 2 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

VAPORIZING CHEST RUB GEL

DECONGESTANT AND COUGH SUPPRESSANT

NET WT. 4 OZ (113g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VAPORIZING CHEST RUB 
menthol and camphor and eucalyptus oil gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69274-003
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
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
NUTMEG OIL (UNII: Z1CLM48948)
TURPENTINE OIL (UNII: C5H0QJ6V7F)
THYMOL (UNII: 3J50XA376E)
CEDAR LEAF OIL (UNII: BJ169U4NLG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69274-003-08	50 g in 1 BOTTLE, PLASTIC
2	NDC: 69274-003-09	56.6 g in 1 BOTTLE, PLASTIC
3	NDC: 69274-003-10	100 g in 1 BOTTLE, PLASTIC
4	NDC: 69274-003-11	113 g in 1 BOTTLE, PLASTIC
5	NDC: 69274-003-12	150 g in 1 BOTTLE, PLASTIC
6	NDC: 69274-003-13	170 g in 1 BOTTLE, PLASTIC
7	NDC: 69274-003-14	226 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/25/2014

Labeler - FOUR SEASONS TRADING INC (169331464)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(69274-003)