EAGLE BRAND MEDICATED ROLL ON AROMATIC- camphor, menthol, methyl salicylate oil 
PT. EAGLE INDO PHARMA

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Eagle Brand Medicated Roll On Aromatic

Active ingredients

Purpose

External Analgesic

Uses

For temporary relief of minor aches and pains 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 or damaged skin.
  • Do not bandage tightly.
  • Do not use otherwise than as directed.

Stop use and ask doctor if

  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Excessive skin irritation develops.

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children

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

Directions

Other information

Store below 86 oF (30 oC).

Inactive ingredients

Eucalyptus oil, light mineral oil, spike lavender oil

Questions?

If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

Package Label

8ml NDC: 60954-017-08

8ml Unit Box

EAGLE BRAND  MEDICATED ROLL ON AROMATIC
camphor, menthol, methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE35 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)7 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60954-017-081 in 1 BOX11/01/2023
18 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/01/2023
Labeler - PT. EAGLE INDO PHARMA (728682519)
Establishment
NameAddressID/FEIBusiness Operations
PT. EAGLE INDO PHARMA728682519manufacture(60954-017)

Revised: 1/2025
Document Id: 2c2ead12-0fa5-f5cd-e063-6394a90a7b47
Set id: 0f333f93-bec6-72d5-e063-6394a90a4e3f
Version: 2
Effective Time: 20250120
 
PT. EAGLE INDO PHARMA