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NDC 60954-0002-03 Eagle 14.5; 30 g/100mL; g/100mL Details

Eagle 14.5; 30 g/100mL; g/100mL

Eagle 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	60954-0002
Product ID	60954-002_da33ffbe-b4a9-5420-e053-2a95a90a22db
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
Proprietary Name Suffix	Medicated
Non-Proprietary Name	Menthol Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	TOPICAL
Active Ingredient Strength	14.5; 30
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 60954-0002-03 (60954000203)

Pricing Information	N/A
NDC Package Code	60954-002-03
Billing NDC	60954000203
Package	1 BOTTLE, GLASS in 1 BOX (60954-002-03) / 3 mL in 1 BOTTLE, GLASS
Marketing Start Date	2022-03-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL da338796-de9c-be51-e053-2a95a90a2509 Details

Active Ingredient

Menthol 14.5%

Methyl Salicylate 30.0%

Purpose

Topical Analgesic

Uses

temporarily relieves minor muscle and joint pain due to : ■ simple backache ■ arthritis ■ strains ■ bruises

■ sprains

Warnings

For external use only

When using this product

■ use only as directed

■ do not get into eyes or mucous membranes

■ do not apply to wound or damaged skin.

■ do not bandage tightly

Stop use and ask a doctor if

■ excessive skin irritation develops

■ pain worsens or does not improve within 7 days, or clears up and appears again in a few days

Keep this drug out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ 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

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

Package Label

INGREDIENTS AND APPEARANCE

EAGLE MEDICATED

menthol methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60954-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 g in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
ALCOHOL (UNII: 3K9958V90M)
MINERAL OIL (UNII: T5L8T28FGP)
ROSE OIL (UNII: WUB68Y35M7)
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60954-002-24	1 in 1 BOX	03/04/2022
1		24 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC:60954-002-36	1 in 1 BOX	03/04/2022
2		36 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3	NDC:60954-002-03	1 in 1 BOX	03/04/2022
3		3 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	03/04/2022

Labeler - Eagle Indo Pharma, PT (728682519)

Name	Address	ID/FEI	Business Operations
Establishment
Eagle Indo Pharma, PT		728682519	manufacture(60954-002)

Revised: 3/2022

Document Id: da33ffbe-b4a9-5420-e053-2a95a90a22db

Set id: da338796-de9c-be51-e053-2a95a90a2509

Version: 2

Effective Time: 20220314