Search by Drug Name or NDC

NDC 60954-0007-03 Eagle 7; 16; 35 g/100mL; g/100mL; g/100mL Details

Eagle 7; 16; 35 g/100mL; 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 CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE.

Product Information

NDC	60954-0007
Product ID	60954-007_e272f955-1264-f8b8-e053-2a95a90a2aaf
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 Aromatic
Non-Proprietary Name	Camphor Menthol Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	TOPICAL
Active Ingredient Strength	7; 16; 35
Active Ingredient Units	g/100mL; g/100mL; g/100mL
Substance Name	CAMPHOR (SYNTHETIC); 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 60954-0007-03 (60954000703)

Pricing Information	N/A
NDC Package Code	60954-007-03
Billing NDC	60954000703
Package	1 BOTTLE, GLASS in 1 BOX (60954-007-03) / 3 mL in 1 BOTTLE, GLASS
Marketing Start Date	2022-06-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e272ec90-3cd9-5b70-e053-2a95a90a1df4 Details

Active Ingredients

Camphor 7%

Menthol 16%

Methyl Salicylate 35%

Purpose

Topical Analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joint 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 if 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

eucalyptus oil, spike lavender oil, light mineral oil

Question?

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

Package Label

INGREDIENTS AND APPEARANCE

EAGLE MEDICATED AROMATIC

camphor menthol methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60954-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	7 g in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	35 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTUS OIL (UNII: 2R04ONI662)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60954-007-24	1 in 1 BOX	06/20/2022
1		24 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC:60954-007-03	1 in 1 BOX	06/20/2022
2		3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3	NDC:60954-007-08	1 in 1 BOX	06/20/2022
3		8 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4	NDC:60954-007-12	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(60954-007)

Revised: 6/2022

Document Id: e272f955-1264-f8b8-e053-2a95a90a2aaf

Set id: e272ec90-3cd9-5b70-e053-2a95a90a1df4

Version: 1

Effective Time: 20220627