EAGLE MEDICATED- menthol methyl salicylate oil 
Eagle Indo Pharma

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 Menthol Mthylslcylte Oil

Active Ingredients

Menthol 14.5%
Methyl Salicylate 30%

Purpose

Topical Analgesic

Topical Analgesic

Uses

temporarily relieves the minor aches and pains of muscle and joints associated with :

■simple backache ■strains ■bruises ■sprains

Warning

For external use only

Do not use

■ on wounds or damaged skin ■ with a heating pad

Ask a doctor before use if

you have redness over affected area

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 out of reach of children

Keep 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 over: 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 1-800-645-0769

Package Label

package label

EAGLE  MEDICATED
menthol methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-008
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)  
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
ALCOHOL (UNII: 3K9958V90M)  
MINERAL OIL (UNII: T5L8T28FGP)  
ROSE OIL (UNII: WUB68Y35M7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60954-008-241 in 1 BOX06/27/2022
124 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:60954-008-361 in 1 BOX06/27/2022
236 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3NDC:60954-008-031 in 1 BOX06/27/2022
33 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4NDC:60954-008-081 in 1 BOX06/27/2022
48 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 finalpart34806/20/2012
Labeler - Eagle Indo Pharma (728682519)
Establishment
NameAddressID/FEIBusiness Operations
Eagle Indo Pharma728682519manufacture(60954-008)

Revised: 7/2022
Document Id: e2c5efb9-ee9e-9d68-e053-2a95a90ab128
Set id: e2c5f821-cdd5-190d-e053-2a95a90a9159
Version: 1
Effective Time: 20220701
 
Eagle Indo Pharma