eagle brand medicated oil aromatic

eagle brand medicated oil aromatic
SPL v2
SPL
SPL Set ID 0e808f89-62dc-3790-e063-6394a90a2351
Route
topical
Published
Effective Date 2024-01-09
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 2024-01-09

Purpose

External Analgesic

Description

Camphor 7% Menthol 16% Methyl Salicylate 35%


Medication Information

Warnings

For external use only

Uses

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

Purpose

External Analgesic

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

Description

Camphor 7% Menthol 16% Methyl Salicylate 35%

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: 43405-014-24

36ml NDC: 43405-014-36

Active Ingredients
  • Camphor 7%
  • Menthol 16%
  • Methyl Salicylate 35%
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 Ouf of Reach of Children

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


Structured Label Content

Warnings

For external use only

Uses

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

Purpose

External Analgesic

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 (Other information)

Store below 86 oF (30 oC).

Inactive Ingredients (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

24ml NDC: 43405-014-24

36ml NDC: 43405-014-36

Active Ingredients
  • Camphor 7%
  • Menthol 16%
  • Methyl Salicylate 35%
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 Ouf of Reach of Children (Keep ouf 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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