Eagle Brand Medicated Oil Refresh

Eagle Brand Medicated Oil Refresh
SPL v3
SPL
SPL Set ID 09260c31-56a3-07aa-e063-6394a90a95fd
Route
TOPICAL
Published
Effective Date 2023-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (14 g) Camphor (synthetic) (2.2 g)
Inactive Ingredients
Clove Oil Light Mineral Oil Peppermint Oil D&c Red No. 17 Beta Carotene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-02

Description

Camphor 2.2% Menthol 14%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Camphor 2.2% Menthol 14%

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

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: 60954-013-24

36ml NDC: 60954-013-36

Other Information

Store below 86 oF (30 oC).

Active Ingredients
  • Camphor 2.2%
  • Menthol 14%
Inactive Ingredients

beta carotene, clove oil, D&C Red No.17, fragrance, light mineral oil, peppermint 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 A 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 pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains, and itching associated with • insect bites.

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: 60954-013-24

36ml NDC: 60954-013-36

Other Information (Other information)

Store below 86 oF (30 oC).

Active Ingredients (Active ingredients)
  • Camphor 2.2%
  • Menthol 14%
Inactive Ingredients (Inactive ingredients)

beta carotene, clove oil, D&C Red No.17, fragrance, light mineral oil, peppermint 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 A Doctor If (Stop use and ask a 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

All Sections (JSON)