OTC Medication Information: Eagle Medicated Aromatic

EAGLE MEDICATED AROMATIC- camphor (synthetic), menthol and 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.

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
(click image for full-size original)

EAGLE MEDICATED AROMATIC
camphor menthol methyl salicylate oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60954-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 7 g in 100 mL
MENTHOL (MENTHOL) MENTHOL 16 g in 100 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 35 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
EUCALYPTUS OIL
LIGHT MINERAL OIL
SPIKE LAVENDER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60954-007-24 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
1 24 mL in 1 BOTTLE, GLASS This package is contained within the BOX (60954-007-24)
2 NDC:60954-007-03 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
2 3 mL in 1 BOTTLE, GLASS This package is contained within the BOX (60954-007-03)
3 NDC:60954-007-08 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
3 8 mL in 1 BOTTLE, GLASS This package is contained within the BOX (60954-007-08)
4 NDC:60954-007-12 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
4 12 mL in 1 BOTTLE, GLASS This package is contained within the BOX (60954-007-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/20/2022
Labeler — Eagle Indo Pharma, PT (728682519)
Establishment
Name Address ID/FEI Operations
Eagle Indo Pharma, PT 728682519 manufacture (60954-007)

Revised: 06/2022 Eagle Indo Pharma, PT

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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