Eagle

Manufacturer: Eagle Indo Pharma
Effective date: 2024-10-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:23:08

Label at a glance#

ProductEagle Medicated

Active ingredientMENTHOL, METHYL SALICYLATE

Label structure13 sections

Indications and uses

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

Dosage and administration

■ Use only as directed ■adults and children 2 years and over: apply to affected area not more than 3 to 4 time daily ■children under 2 years of age: ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-777-6717

PhoneLabel contact1-800-645-0769

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 14.5%
Methyl Salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscle and joints associated with :

■simple backache ■strains ■bruises ■sprains

Warning

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ on wounds or damaged skin ■ with a heating pad

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have redness over affected area

When using this product

OTC - WHEN USING SECTION

■avoid contact with eyes or mucous membranes ■do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

■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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenTo avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use only as directed ■adults and children 2 years and over: apply to affected area not more than 3 to 4 time daily ■children under 2 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Green No. 6, D&C Yellow No. 11, ethyl alcohol, mineral oil, rose oil

Question?

OTC - QUESTIONS SECTION

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1293435	EAGLE BRAND Medicated 14.5 % / 30 % Topical Oil	PSN	2
1293430	menthol 14.5 % / methyl salicylate 30 % Topical Oil	PSN	2
1293435	menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]	SBD	2
1293430	menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil	SCD	2
1293435	Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical Oil	SY	2
1293435	Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical Oil	SY	2
1293430	menthol 14.5 % / methyl salicylate 30 % Topical Oil	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60954-008-03	EagleMedicated	1 in 1 BOX	OIL	1	2
60954-008-03	EagleMedicated	3 mL in 1 BOTTLE, GLASS	OIL	3	2
60954-008-08	EagleMedicated	1 in 1 BOX	OIL	1	2
60954-008-08	EagleMedicated	8 mL in 1 BOTTLE, GLASS	OIL	8	2
60954-008-24	EagleMedicated	24 mL in 1 BOTTLE, GLASS	OIL	24	2
60954-008-24	EagleMedicated	1 in 1 BOX	OIL	1	2
60954-008-36	EagleMedicated	36 mL in 1 BOTTLE, GLASS	OIL	36	2
60954-008-36	EagleMedicated	1 in 1 BOX	OIL	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60954-008	EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [EAGLE INDO PHARMA]	2	Current NDC, Legacy NDC, 8 package rows	20241009_e2c5f821-cdd5-190d-e053-2a95a90a9159.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Eagle Medicated
Menthol Methyl Salicylate
D&C YELLOW NO. 11
D&C GREEN NO. 6
ALCOHOL
MINERAL OIL
ROSE OIL
MENTHOL
METHYL SALICYLATE
SALICYLIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60954-008	60954-008-24, 60954-008-36, 60954-008-03, 60954-008-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
D&C YELLOW NO. 11	44F3HYL954	IACT
D&C GREEN NO. 6	4QP5U84YF7	IACT
ALCOHOL	3K9958V90M	IACT
MINERAL OIL	T5L8T28FGP	IACT
ROSE OIL	WUB68Y35M7	IACT
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma	e2c5f821-cdd5-190d-e053-2a95a90a9159	2024-10-07	Warnings	Exact identifier ndc (package): 60954-008-36 ndc (package): 60954-008-03 ndc (package): 60954-008-08 ndc (package): 60954-008-24 ndc (product): 60954-008 ndc11 (package): 60954000803 ndc11 (package): 60954000836 ndc11 (package): 60954000808 ndc11 (package): 60954000824 spl id: 23dc4921-4049-2501-e063-6394a90a4932 spl set id: e2c5f821-cdd5-190d-e053-2a95a90a9159

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.