EAGLE BRAND MEDICATED ROLL ON AROMATIC- camphor, menthol, methyl salicylate oil

Eagle Brand by

Drug Labeling and Warnings

Eagle Brand by is a Otc medication manufactured, distributed, or labeled by PT. EAGLE INDO PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

• Camphor 7%
• Menthol 16%
• Methyl Salicylate 35%

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

• 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, 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

INGREDIENTS AND APPEARANCE

EAGLE BRAND  MEDICATED ROLL ON AROMATIC
camphor, menthol, methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60954-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60954-017-08	1 in 1 BOX	11/01/2023
1		8 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/01/2023

Labeler - PT. EAGLE INDO PHARMA (728682519)

Establishment
Name	Address	ID/FEI	Business Operations
PT. EAGLE INDO PHARMA		728682519	manufacture(60954-017)