EAGLE MEDICATED OIL REFRESHING- menthol, methyl salicylate oil 
Eagle Indo Pharma, PT

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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Refreshing External Analgesic OIl

Active Ingredients

Menthol 14%

Methyl Salicylate 15%

Purpose

Topical Analgesic

Topical Analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with ■simple backache ■strains ■bruises ■ sprains

Warning

For external use only

Do not use

■ on wounds or damaged skin ■ with a heatng pad

Ask a doctor before use if

you have readness over affected area

When using this product

■ avoid contact with eyes or on 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 of age and older: apply to affected area not more than 3 to 4 times daily. ■ children under 2 years of age: ask a doctor

Inactive Ingredients

clove oil, eucalyptus oil, fragrance, light mineral oil

Question?

1-800-777-6717 or 1-800-645-0769

Package Label

package label

EAGLE MEDICATED OIL  REFRESHING
menthol, methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CLOVE OIL (UNII: 578389D6D0)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60954-005-241 in 1 BOX06/20/2022
124 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:60954-005-081 in 1 BOX06/20/2022
28 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3NDC:60954-005-031 in 1 BOX06/20/2022
33 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4NDC:60954-005-121 in 1 BOX06/20/2022
412 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 finalpart34806/20/2022
Labeler - Eagle Indo Pharma, PT (728682519)
Establishment
NameAddressID/FEIBusiness Operations
Eagle Indo Pharma, PT728682519manufacture(60954-005)

Revised: 6/2022
Document Id: e272d1ce-30af-815f-e053-2a95a90aeb8b
Set id: e2729023-d689-7ae2-e053-2a95a90a78dc
Version: 1
Effective Time: 20220627
 
Eagle Indo Pharma, PT