eagle brand muscular balm

eagle brand muscular balm
SPL v1
SPL
SPL Set ID 3caf2d2c-8472-2587-e063-6294a90a4c4f
Route
topical
Published
Effective Date 2025-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (1.222 g) salicylic acid (2.466 g)
Inactive Ingredients
white petrolatum paraffin camphor oil, white

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-19

Purpose

External Analgesic

Description

Menthol 12.22% Methyl Salicylatre 24.66%


Medication Information

Warnings

For external use only.

Uses

For the 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

Camphor oil white, paraffin, white petrolatum

Description

Menthol 12.22% Methyl Salicylatre 24.66%

Questions?

If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

Package Label

10g NDC: 60954-299-10

20g NDC: 60954-299-20

Active Ingredients
  • Menthol 12.22%
  • Methyl Salicylatre 24.66%
When Using This Product
  • Avoid getting into the eyes or mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use if excessive irritation of the skin develops.
  • 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

Warnings

For external use only.

Uses

For the 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)

Camphor oil white, paraffin, white petrolatum

Questions?

If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

Package Label (Package label)

10g NDC: 60954-299-10

20g NDC: 60954-299-20

Active Ingredients (Active ingredients)
  • Menthol 12.22%
  • Methyl Salicylatre 24.66%
When Using This Product (When using this product)
  • Avoid getting into the eyes or mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use if excessive irritation of the skin develops.
  • 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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