VAPORIZING CHEST RUB COUGH SUPRESSANT (camphor- synthetic, eucalyptus oil, and menthol ointment

Vaporizing Chest Rub by

Drug Labeling and Warnings

Vaporizing Chest Rub by is a Otc medication manufactured, distributed, or labeled by Filo America, Ningbo Pulisi Daily Chemical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Camphor 4.7%: Cough suppressant/topical analgesic
• Eucalyptus oil 1%: Cough suppressant
• Menthol, natural 1%: Cough suppressant / topical analgesic

Use

when applied to chest and throat

• temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

when applied to muscles and joints

• temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only; avoid contact with eyes.

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
• do not microwave
• do not add to hot water or any container where heating water. May cause splattering and result in burns.
• do not take by mouth or place in nostrils

Stop use and ask a doctor if

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• see important warnings under "When using this product"
• adults and children 2 year and over.

for cough suppression

• rub a thick layer on the throat and chest
• cover with a warm, dry cloth if desired
• keep clothing loose about throat and chest to help vapors reach the nose and mouth
• use up to 3 times daily, or as directed by a doctor

for muscle/joint minor aches and pains apply

• to affected area not more than 3-4 times daily
• children under 2 yeas : ask a doctor

other information

• store at room temperature

if pregnant or breast feeding

• ask a health professional before use

Inactive ingredients

Cedar leaf oil, methylparaben, Nutmeg oil, petrolatum, Turpentine oil, Thymol, propylparaben

PRINCIPAL DISPLAY PANEL - 100g Jar Label

VAPORIZING
CHEST RUB

4 oz (113g)

INGREDIENTS AND APPEARANCE

VAPORIZING CHEST RUB  COUGH SUPRESSANT
camphor (synthetic), eucalyptus oil, and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50438-502
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
Eucalyptus Oil (UNII: 2R04ONI662) (Eucalyptus Oil - UNII:2R04ONI662)	Eucalyptus Oil	1 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Nutmeg Oil (UNII: Z1CLM48948)	0.6 g  in 100 g
TURPENTINE OIL (UNII: C5H0QJ6V7F)
Petrolatum (UNII: 4T6H12BN9U)
propylparaben (UNII: Z8IX2SC1OH)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50438-502-01	113 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 final	part341	05/05/2015

Labeler - Filo America (943873703)

Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.		529047265	manufacture(50438-502)