EAGLE MEDICATED OIL REFRESHING- menthol, methyl salicylate oil

Eagle Medicated Oil by

Drug Labeling and Warnings

Eagle Medicated Oil by is a Otc medication manufactured, distributed, or labeled by Eagle Indo Pharma, PT. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 childrenTo 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

INGREDIENTS AND APPEARANCE

EAGLE MEDICATED OIL  REFRESHING
menthol, methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60954-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CLOVE OIL (UNII: 578389D6D0)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60954-005-24	1 in 1 BOX	06/20/2022
1		24 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 60954-005-08	1 in 1 BOX	06/20/2022
2		8 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3	NDC: 60954-005-03	1 in 1 BOX	06/20/2022
3		3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4	NDC: 60954-005-12	1 in 1 BOX	06/20/2022
4		12 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/20/2022

Labeler - Eagle Indo Pharma, PT (728682519)

Establishment
Name	Address	ID/FEI	Business Operations
Eagle Indo Pharma, PT		728682519	manufacture(60954-005)