AVEDANA MEDICATED CHEST RUB- camphor eucalyptus menthol ointment 
Unipack LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AVEDANA ® MEDICATED CHEST RUB

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

Label

AVEDANA MEDICATED CHEST RUB 
camphor eucalyptus menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 OIL1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U) 91.05 g  in 100 g
NUTMEG OIL (UNII: Z1CLM48948) 0.15 g  in 100 g
TURPENTINE (UNII: XJ6RUH0O4G) 0.05 g  in 100 g
CEDAR LEAF OIL (UNII: BJ169U4NLG) 0.05 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP) 0.05 g  in 100 g
THYMOL (UNII: 3J50XA376E) 0.05 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-110-04113 g in 1 JAR; Type 0: Not a Combination Product09/03/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/03/2014
Labeler - Unipack LLC (009248480)
Registrant - Unipack LLC (009248480)
Establishment
NameAddressID/FEIBusiness Operations
Unipack LLC009248480manufacture(43749-110)

Revised: 1/2023
Document Id: f28f8a35-cbb1-21bc-e053-2995a90adb2c
Set id: b38c736a-d1a0-4eae-9696-0ea8a1a9c8f3
Version: 6
Effective Time: 20230118
 
Unipack LLC