EAGLE BRAND MEDICATED ROLL ON REFRESH- camphor, menthol oil

Eagle Brand by

Drug Labeling and Warnings

Eagle Brand by is a Otc medication manufactured, distributed, or labeled by Borden Company (Private) Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

• Camphor 2.2%
• Menthol 14%

Purpose

External Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains, and itching associated with insect bites.

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.

Keep out of reach of children

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

If pregnant or breast-feeding

Ask a health professional before use.

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

beta carotene, clove oil, D&C Red No.17, fragrance, light mineral oil, peppermint 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: 43405-012-08

INGREDIENTS AND APPEARANCE

EAGLE BRAND  MEDICATED ROLL ON REFRESH
camphor, menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43405-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2.2 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CLOVE OIL (UNII: 578389D6D0)
BETA CAROTENE (UNII: 01YAE03M7J)
D&C RED NO. 17 (UNII: ND733RX3JN)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43405-012-08	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 - Borden Company (Private) Limited (595109711)

Establishment
Name	Address	ID/FEI	Business Operations
Borden Company (Private) Limited		595109711	manufacture(43405-012)