EAGLE EXTRA STRENGTH- menthol methyl salicylate liquid 
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.

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Active Ingredients

Menthol 14.5%
Methyl Salicylate 30%


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

alcohol, camphor, thymol

Package Label

Package Labelimage description

EAGLE  EXTRA STRENGTH
menthol methyl salicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14.5 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
THYMOL (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43405-010-011 in 1 BOX06/15/2015
1NDC:43405-010-8585 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) Limited595109711manufacture(43405-010)

Revised: 10/2022
Document Id: eade2db4-2ba6-6004-e053-2a95a90aac62
Set id: 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0
Version: 3
Effective Time: 20221012
 
Borden Company (Private) Limited