XTRACARE VAPORIZING CHEST RUB- camphor, menthol gel

XtraCare Vaporizing Chest Rub by

Drug Labeling and Warnings

XtraCare Vaporizing Chest Rub by is a Otc medication manufactured, distributed, or labeled by Rejoice International, China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                 Purpose

Camphor 4.8% ..................................... Cough Suppressant

Menthol 1.0% ............................................ Topical Analgesic

PURPOSE

Uses

• on chest and throat, temporarily relieves cough as may occur with common cold and minor bronchial irritation.
• for the temporary relief of pain associated with minor skin irritation.

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

XtraCare® Vaporizing Chest Rub

Cough Suppressant

Net Wt 4 Oz (113 g)

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

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

DOSAGE & ADMINISTRATION

Directions

• see important warnings under "When using this product"
• adults and children 2 years old and older:
• rub a thick layer on chest & throat or rub on sore aching muscles
• cover with a warm, dry cloth if desired
• keep clothing loose about throat chest to help vapors reach the nose/mouth
• repeat up to three times per 24 hours or as directed by doctor
• children under 2 years: do not use

INACTIVE INGREDIENT

Inactive Ingredients:

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

OTHER SAFETY INFORMATION

Other Information:store at room temperature

Questions/Comments?1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE VAPORIZING CHEST RUB 
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5 g  in 113 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 113 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: 57337-051-01	113 g in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/30/2014

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(57337-051)