EAGLE MEDICATED- 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.

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Eagle Brand Medicated Oil Rollon

Active Ingredients

Menthol 14.5%
Methyl Salicylate 30%

Purpose

Topical Analgesic

Topical Analgesic

Uses

temporarily relieves the minor aches and pains of muscle and joint associated with : ■ simple backache ■ strains ■ bruises ■ sprains

Warning

For external use only

Do not use

■ on woulds or damaged skin ■ with a heating pad

When using this product

■ avoid contact with eyes or mucous membranes

■ do not bandage tightly

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive skin irritation occurs

Keep this drug out of reach of children

To avoid accidental poisoning, if swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Use only as directed ■ adults and children 2 years and older: apply to affected area not more than 3 to 4 time daily. ■ children under 2 years of age: ask a doctor

Inactive ingredients

D&C Green No. 6, D&C Yellow No. 11, ethyl alcohol, mineral oil, rose oil

Question?

1-800-777-6717 or 1-800-645-0789

Package Label

package label

EAGLE  MEDICATED
menthol methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-005
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
D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
ALCOHOL (UNII: 3K9958V90M)  
MINERAL OIL (UNII: T5L8T28FGP)  
ROSE OIL (UNII: WUB68Y35M7)  
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43405-005-081 in 1 BOX03/04/2022
18 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/04/2022
Labeler - Borden Company (Private) Limited (595109711)
Establishment
NameAddressID/FEIBusiness Operations
Borden Company (Private) Limited595109711manufacture(43405-005)

Revised: 3/2022
Document Id: da33ae72-a960-2252-e053-2a95a90aa90c
Set id: da3358ae-8679-6045-e053-2a95a90a50e3
Version: 1
Effective Time: 20220314
 
Borden Company (Private) Limited