Eagle Brand Medicated Roll On

Eagle Brand Medicated Roll On
SPL v1
SPL
SPL Set ID 1bd5cf69-9a08-5e2e-e063-6394a90a03cd
Route
TOPICAL
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (30 g) Menthol (14.5 g)
Inactive Ingredients
Rose Oil Alcohol D&c Green No. 6 Beta Carotene Peppermint Oil Eucalyptus Oil Light Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-24
Description

Menthol 14.5% Methyl Salicylate 30%

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Menthol 14.5% Methyl Salicylate 30%

Uses

For temporary relief of minor aches and pains 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

8ml NDC: 43405-016-08

Other Information

Store below 86 oF (30 oC).

Active Ingredients
  • Menthol 14.5%
  • Methyl Salicylate 30%
Inactive Ingredients

Alcohol, beta carotene, D&C Green No.6, eucalyptus oil, fragrance, light mineral oil, peppermint oil, rose 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.
  • Excessive skin irritation develops.
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.

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

8ml NDC: 43405-016-08

Other Information (Other information)

Store below 86 oF (30 oC).

Active Ingredients (Active ingredients)
  • Menthol 14.5%
  • Methyl Salicylate 30%
Inactive Ingredients (Inactive ingredients)

Alcohol, beta carotene, D&C Green No.6, eucalyptus oil, fragrance, light mineral oil, peppermint oil, rose 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.
  • Excessive skin irritation develops.
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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.030460 · Updated: 2026-03-14T23:03:09.210552