AVEDANA MEDICATED CHEST RUB- camphor eucalyptus menthol ointment

Avedana Medicated Chest Rub by

Drug Labeling and Warnings

Avedana Medicated Chest Rub by is a Otc medication manufactured, distributed, or labeled by Unipack LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ingredients                   Purpose

Camphor 4.8%             cough suppressant/topical analgesic

Eucalyptus Oil 1.2%      cough suppressant

Menthol 2.6%               cough supressant/topical analgesic

Uses

Uses - On chest and throat, temporarily relieves cough due to common cold.  On the muscles and joints, temporarily relieves minor aches and pains.

Warnings

Warnings

For external use only.  Avoid contact with eyes.

Do Not Use

Do not use - by mouth - in nostrils - on wounds or damaged skin - with tight bandages

Ask a doctor before use if you have

asthma - excessive phlegm (mucus) - emphysema - persistent or chronic cough - cough associated with smoking

If pregnant or breast-feeding

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

Keep out of reach of children

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

Directions

- children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on throat and chest or rub on sore aching muscles.  If desired cover with a dry soft cloth, but keep clothing loose.  Repeat up to 3 times a day.

Other information

store at room temperature

Other Ingredients

Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol

Purpose

cough suppressant / topical analgesic, cough suppressant

Product Label

INGREDIENTS AND APPEARANCE

AVEDANA MEDICATED CHEST RUB 
camphor eucalyptus menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-110
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
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)	91.05 g  in 100 g
NUTMEG OIL (UNII: Z1CLM48948)	.15 g  in 100 g
TURPENTINE (UNII: XJ6RUH0O4G)	.05 g  in 100 g
CEDAR LEAF OIL (UNII: BJ169U4NLG)	.05 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP)	.05 g  in 100 g
THYMOL (UNII: 3J50XA376E)	.05 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-110-04	113 g in 1 JAR; Type 0: Not a Combination Product	09/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/03/2014

Labeler - Unipack, Inc. (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(43749-110)