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NDC 60954-0005-03 Eagle Medicated Oil 14; 15 g/100mL; g/100mL Details

Eagle Medicated Oil 14; 15 g/100mL; g/100mL

Eagle Medicated Oil is a TOPICAL OIL in the HUMAN OTC DRUG category. It is labeled and distributed by Eagle Indo Pharma, PT. The primary component is MENTHOL; METHYL SALICYLATE.

Product Information

NDC	60954-0005
Product ID	60954-005_e272d1ce-30af-815f-e053-2a95a90aeb8b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Eagle Medicated Oil
Proprietary Name Suffix	Refreshing
Non-Proprietary Name	Menthol, Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	TOPICAL
Active Ingredient Strength	14; 15
Active Ingredient Units	g/100mL; g/100mL
Substance Name	MENTHOL; METHYL SALICYLATE
Labeler Name	Eagle Indo Pharma, PT
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 60954-0005-03 (60954000503)

Pricing Information	N/A
NDC Package Code	60954-005-03
Billing NDC	60954000503
Package	1 BOTTLE, GLASS in 1 BOX (60954-005-03) / 3 mL in 1 BOTTLE, GLASS
Marketing Start Date	2022-06-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e2729023-d689-7ae2-e053-2a95a90a78dc Details

Active Ingredients

Menthol 14%

Methyl Salicylate 15%

Purpose

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/20/2022

Labeler - Eagle Indo Pharma, PT (728682519)

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

Revised: 6/2022

Document Id: e272d1ce-30af-815f-e053-2a95a90aeb8b

Set id: e2729023-d689-7ae2-e053-2a95a90a78dc

Version: 1

Effective Time: 20220627