VAPORIZING CHEST RUB 4 OZ.- camphor, eucalyptus oil, menthol ointment

Vaporizing Chest Rub 4 oz. by

Drug Labeling and Warnings

Vaporizing Chest Rub 4 oz. by is a Otc medication manufactured, distributed, or labeled by Rejoice International Inc., China Ningbo Shangge Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Camphor, 4.8%

Eucalyptus Oil, 1.2%

Menthol, 2.6%

PURPOSE

Purpose

Cough suppressant & topical analgesic

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.

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 a doctor before use if you have

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

When using this product, do not

• heat
• microwave
• add to hot water or any container where heating water. May cause spattering and result in burns.

Stop use and ask a doctor if

• muscles aches and pains persist more than 7 days or come back
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headche. These could be signs of a serious condition.

DOSAGE & ADMINISTRATION

Directions

• See important warnings under "When using this product"
• adults and children 2 years and older

For cough suppression

• rub a thick layer on chest & throat
• cover with a warm, dry cloth if desired
• keep clothing loose and throat and chest to help vapors reach the nose and mouth
• use up to 3 times daily or as directed as doctor
• for muscle / joint minor aches and pains apply to affected areas not more than 3 to 4 times daily
• children under 2 years; do not use

INACTIVE INGREDIENT

Inactive ingredients

Cedarleaf Oil, Nutmeg Oil, Petrolatum, Thymol, Turpentine Oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VAPORIZING CHEST RUB 4 OZ. 
camphor, eucalyptus oil, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-097
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4.8 g  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.2 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-097-01	1 in 1 BOX	07/20/2018
1		113 mL 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 not final	part348	07/20/2018

Labeler - Rejoice International Inc. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Technology Co., Ltd.		529287434	manufacture(57337-097)