Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

EAGLE MEDICATED AROMATIC- camphor menthol methyl salicylate oil 
Borden Company (Private) Limited

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.

----------

Drug Facts

Active Ingredients

Camphor 7%

Menthol 16%
Methyl Salicylate 35%

Purpose

External Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joint associated with ■ simple backache ■ arthritis ■ strains

■ bruises ■ sprains

Warnings

For external use only ■ Avoid getting into eyes and mucous membranes

When using this product

■ do not apply to wound or damaged skin ■ do not bandage tightly ■ do not use otherwise than as directed

Stop use and ask a doctor if

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ pain persists for more than 10 days ■ redness is present ■ conditions affect children under 12 years of age

Keep this drug out of reach of children

to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use 

Directions

■ adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily. ■ apply liberally and gently rub into affected area ■ children under 12 years of age, consult a doctor before using.

Inactive ingredients

eucalyptus oil, light mineral oil, spkike lavender oil

Package Label

image description

EAGLE  MEDICATED AROMATIC
camphor menthol methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43405-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)7 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE35 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ALCOHOL (UNII: 3K9958V90M)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43405-009-011 in 1 BOX
1NDC: 43405-009-2424 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC: 43405-009-131 in 1 BOX
2NDC: 43405-009-033 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/15/2015
Labeler - Borden Company (Private) Limited (595109711)
Establishment
NameAddressID/FEIBusiness Operations
Borden Company (Private) Limited 595109711manufacture(43405-009)

Revised: 6/2015
 
Borden Company (Private) Limited


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.