CHEST RUB VAPORIZING- menthol and camphor and eucalyptus oil gel

Chest Rub Vaporizing by

Drug Labeling and Warnings

Chest Rub Vaporizing by is a Otc medication manufactured, distributed, or labeled by North & South Wholesalers LLC, 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

Decongestant

INDICATIONS & USAGE

Uses

• on chest and throat, helps temporarily relieve cough due to common cold
• on joints and muscles, temporary relieves minor aches and pain

WARNINGS

Warnings

For external use only, avoid contact with eyes.

DO NOT USE

Do not use

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

ASK DOCTOR

Ask doctor before use if you have,

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

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 lasts more than 7 days, comes back, or fever, rash or persistent headache. These could be sign of a serious conditions
• muscle aches and pain persist more than 7 days

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:

adults and children 2 years and over:

• rub a thick layer on chest and throat or rub on sore aching muscles
• keep clothing loose around chest/throat to help vapors reach the nose/mouth
• repeat up to 3 times per 24 hours or as directed by doctor

do not use on children under 2 years unless directed by doctor

INACTIVE INGREDIENT

Inactive Ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, and turpentine oil

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

CHEST RUB VAPORIZING GEL

NASAL DECONGESTANT

COUGH SUPPRESSANT

NET WT. 4 OZ (113g)

INGREDIENTS AND APPEARANCE

CHEST RUB VAPORIZING 
menthol and camphor and eucalyptus oil gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70201-004
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: 70201-004-09	113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/03/2015

Labeler - North & South Wholesalers LLC (004948495)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(70201-004)