Active Ingredients

Camphor 7%
Menthol 16%
Methyl Salicylate 35%

Purpose

External Analgesic

Uses

For temporary relief of minor aches and pain 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.

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

• 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: do not use, consult a doctor.

Other Information

Store below 86 oF (30 oC).

Inactive Ingredients

eucalyptus oil, light mineral oil, lavender spike 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

24ml NDC: 60954-014-24

24ml Unit Box

36ml NDC: 60954-014-36

36ml Unit Box

EAGLE BRAND MEDICATED OIL AROMATIC
camphor, menthol, methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60954-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	7 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60954-014-24	1 in 1 BOX	11/01/2023
1		24 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC:60954-014-36	1 in 1 BOX	11/01/2023
2		36 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 Drug	M017	11/01/2023

Labeler - PT. EAGLE INDO PHARMA (728682519)

Name	Address	ID/FEI	Business Operations
Establishment
PT. EAGLE INDO PHARMA		728682519	manufacture(60954-014)

Eagle Brand Medicated Oil Aromatic