Eagle Medicated Oil Refreshing: Package Insert and Label Information

EAGLE MEDICATED OIL REFRESHING- methyl salicylate and menthol 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

Menthol 14%

Methyl Salicylate 15%

Purpose

External Analgesic

External Analgesic

Uses

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

Warnings

For external use only

When using this product

■ avoid getting into the eyes or on mucous membranes

■ do not apply to wounds and damaged skin

■ do not bandage tightly or use with a heating pad

■ do not use otherwise tha as directed

Stop use and ask a doctor if

■ condition worsens, ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ redness is present

Keep out of reach of children

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion contact a doctor or Poison Control Center immediately

Directions

■ adults and children 12 years of age: apply to affected area not more than 3 to 4 times daily. ■ children under 12 years of age, consult a doctor before using

Inactive Ingredients

clove oil, eucalyptus oil, fragrance, light mineral oil

Package Label

package label
(click image for full-size original)

EAGLE MEDICATED OIL REFRESHING
menthol, methyl salicylate oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43405-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 15 g in 100 mL
MENTHOL (MENTHOL) MENTHOL 14 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CLOVE OIL
LIGHT MINERAL OIL
EUCALYPTUS OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43405-102-24 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
1 24 mL in 1 BOTTLE, GLASS This package is contained within the BOX (43405-102-24)
2 NDC:43405-102-08 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
2 8 mL in 1 BOTTLE, GLASS This package is contained within the BOX (43405-102-08)
3 NDC:43405-102-03 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
3 3 mL in 1 BOTTLE, GLASS This package is contained within the BOX (43405-102-03)
4 NDC:43405-102-12 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
4 12 mL in 1 BOTTLE, GLASS This package is contained within the BOX (43405-102-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/30/2021
Labeler — Borden Company (Private) Limited (595109711)
Establishment
Name Address ID/FEI Operations
Borden Company (Private) Limited 595109711 manufacture (43405-102)
Establishment
Name Address ID/FEI Operations
Eagle Indo Pharma, PT 728682519 manufacture (43405-102)

Revised: 06/2022 Borden Company (Private) Limited

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