Eagle Brand Medicated Oil Aromatic

Eagle Brand Medicated Oil Aromatic
SPL v2
SPL
SPL Set ID 0ef7c3aa-94a3-9fe9-e063-6394a90ab13d
Route
TOPICAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g) Salicylic Acid (35 g) Camphor (synthetic) (7 g)
Inactive Ingredients
Light Mineral Oil Eucalyptus Oil Spike Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01

Description

Camphor 7% Menthol 16% Methyl Salicylate 35%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Camphor 7% Menthol 16% Methyl Salicylate 35%

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

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.

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

36ml NDC: 60954-014-36

Other Information

Store below 86 oF (30 oC).

Active Ingredients
  • Camphor 7%
  • Menthol 16%
  • Methyl Salicylate 35%
Inactive Ingredients

eucalyptus oil, light mineral oil, lavender spike oil

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.


Structured Label Content

Uses

For temporary relief of minor aches and pain of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains.

Purpose

External Analgesic

Warnings

For external use only

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.

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

36ml NDC: 60954-014-36

Other Information

Store below 86 oF (30 oC).

Active Ingredients
  • Camphor 7%
  • Menthol 16%
  • Methyl Salicylate 35%
Inactive Ingredients

eucalyptus oil, light mineral oil, lavender spike oil

When Using This Product (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 (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 (If pregnant or breast-feeding)

Ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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