EAGLE MEDICATED AROMATIC- camphor 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.

----------

Eagle Medicated Oil Aromatic

Active Ingredients

Camphor 7%

Menthol 16%
Methyl Salicylate 35%

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joint 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 if 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

eucalyptus oil, spike lavender oil, light mineral oil

Question?

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

Package Label

package label

EAGLE  MEDICATED AROMATIC
camphor menthol methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-007
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)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60954-007-241 in 1 BOX06/20/2022
124 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:60954-007-031 in 1 BOX06/20/2022
23 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3NDC:60954-007-081 in 1 BOX06/20/2022
38 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4NDC:60954-007-121 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(60954-007)

Revised: 6/2022
Document Id: e272f955-1264-f8b8-e053-2a95a90a2aaf
Set id: e272ec90-3cd9-5b70-e053-2a95a90a1df4
Version: 1
Effective Time: 20220627
 
Eagle Indo Pharma, PT