MEDICATED CHEST RUB- camphor, menthol, eucalyptus oil cream

Medicated by

Drug Labeling and Warnings

Medicated by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc, Blue Cross Laboratories, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Camphor 4.8%
Menthol 2.6%
Eucalyptus Oil 1.2%

PURPOSE

Purpose

Cough suppressant /topical analgesic

Cough suppressant /topical analgesic

Cough supressan

INDICATIONS & USAGE

Uses: Temporarily relieves throat and chest

• cough
• nasal congestion due to common cold
• aching muscles
• minor aches and pains

WARNINGS

Warnings

For external use only. Avoid contact with eyes

DO NOT USE

Do not use:

• by mouth
• by nostrils
• on wounds or damaged skin
• with light bandages

ASK DOCTOR

Ask a doctor before use if you have

• asthma
• excessive phlem (mucus)
• emphysema
• persistent or chronic cough
• cough associated with smoking

WHEN USING

When using this product do not heat

• microwave
• use near open flame
• 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

• muscle aches/pain persist more than more than 7 days or come back
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health profesional before use

KEEP OUT OF REACH OF CHILDREN

Keep out reach of children.

In case of accidental ingestion get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• see important warnings when using this product
• children under 2 years of age, ask a doctor before using this product
• adults and children 2 years older, rub a thick layer on chest and and throat or rub on sore,aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily

SPL UNCLASSIFIED SECTION

Other information

• Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients:

cedar leaf oil, nutmeg oil, paraffin, patrolatum, thymol, turpentine oil

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Medicated chest rub

4 oz (113 g)

INGREDIENTS AND APPEARANCE

MEDICATED  CHEST RUB
camphor, menthol, eucalyptus oil cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.8 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CEDAR LEAF OIL (UNII: BJ169U4NLG)
NUTMEG OIL (UNII: Z1CLM48948)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
THYMOL (UNII: 3J50XA376E)
TURPENTINE (UNII: XJ6RUH0O4G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-100-01	113 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/19/2011

Labeler - Family Dollar Services Inc (024472631)

Registrant - Blue Cross Laboratories (008298879)

Establishment
Name	Address	ID/FEI	Business Operations
Blue Cross Laboratories		008298879	manufacture(55319-100)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(55319-100)