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NDC 60954-0008-08 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. The primary component is MENTHOL; METHYL SALICYLATE.

Product Information

NDC	60954-0008
Product ID	60954-008_e2c5efb9-ee9e-9d68-e053-2a95a90ab128
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
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 60954-0008-08 (60954000808)

Pricing Information	N/A
NDC Package Code	60954-008-08
Billing NDC	60954000808
Package	1 BOTTLE, GLASS in 1 BOX (60954-008-08) / 8 mL in 1 BOTTLE, GLASS
Marketing Start Date	2022-06-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e2c5f821-cdd5-190d-e053-2a95a90a9159 Details

Active Ingredients

Menthol 14.5%

Methyl Salicylate 30%

Purpose

Topical Analgesic

Uses

temporarily relieves the minor aches and pains of muscle and joints 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 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 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 Green No. 6, D&C Yellow No. 11, ethyl alcohol, mineral oil, rose oil

Question?

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

Package Label

INGREDIENTS AND APPEARANCE

EAGLE MEDICATED

menthol methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60954-008
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)
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)
ALCOHOL (UNII: 3K9958V90M)
MINERAL OIL (UNII: T5L8T28FGP)
ROSE OIL (UNII: WUB68Y35M7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60954-008-24	1 in 1 BOX	06/27/2022
1		24 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC:60954-008-36	1 in 1 BOX	06/27/2022
2		36 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3	NDC:60954-008-03	1 in 1 BOX	06/27/2022
3		3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4	NDC:60954-008-08	1 in 1 BOX	06/27/2022
4		8 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	06/20/2012

Labeler - Eagle Indo Pharma (728682519)

Name	Address	ID/FEI	Business Operations
Establishment
Eagle Indo Pharma		728682519	manufacture(60954-008)

Revised: 7/2022

Document Id: e2c5efb9-ee9e-9d68-e053-2a95a90ab128

Set id: e2c5f821-cdd5-190d-e053-2a95a90a9159

Version: 1

Effective Time: 20220701