Eagle Medicated Aromatic: Package Insert and Label Information

EAGLE MEDICATED AROMATIC- camphor (synthetic), menthol and methyl salicylate oil
Borden Company (Private) Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Camphor 7%

Menthol 16%
Methyl Salicylate 35%

Purpose

External Analgesic

External Analgesic

External Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joint associated with ■ simple backache ■ arthritis ■ strains

■ bruises ■ sprains

Warnings

For external use only ■ Avoid getting into eyes and mucous membranes

When using this product

■ do not apply to wound or damaged skin ■ do not bandage tightly ■ do not use otherwise than as directed

Stop use and ask a doctor if

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ pain persists for more than 10 days ■ redness is present ■ conditions affect children under 12 years of age

Keep this drug out of reach of children

to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. If pregnant or breast-feeding , ask a health professional before use

Directions

■ adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily. ■ apply liberally and gently rub into affected area ■ children under 12 years of age, consult a doctor before using.

Inactive ingredients

eucalyptus oil, light mineral oil, spike lavender oil

Package Label

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EAGLE MEDICATED AROMATIC
camphor menthol methyl salicylate oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43405-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 7 g in 100 mL
MENTHOL (MENTHOL) MENTHOL 16 g in 100 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 35 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
EUCALYPTUS OIL
LIGHT MINERAL OIL
SPIKE LAVENDER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43405-009-01 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS (43405-009-24)
1 NDC:43405-009-24 24 mL in 1 BOTTLE, GLASS This package is contained within the BOX (43405-009-01)
2 NDC:43405-009-13 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS (43405-009-03)
2 NDC:43405-009-03 3 mL in 1 BOTTLE, GLASS This package is contained within the BOX (43405-009-13)
3 NDC:43405-009-08 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
3 8 mL in 1 BOTTLE, GLASS This package is contained within the BOX (43405-009-08)
4 NDC:43405-009-12 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
4 12 mL in 1 BOTTLE, GLASS This package is contained within the BOX (43405-009-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/15/2015
Labeler — Borden Company (Private) Limited (595109711)
Establishment
Name Address ID/FEI Operations
Borden Company (Private) Limited 595109711 manufacture (43405-009)
Establishment
Name Address ID/FEI Operations
Eagle Indo Pharma, PT 728682519 manufacture (43405-009)

Revised: 06/2022 Borden Company (Private) Limited

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