Kofal Fuerte Ointment 2 Oz (wp)(da)

Kofal Fuerte Ointment 2 Oz (wp)(da)
SPL v6
SPL
SPL Set ID 9cac377d-97bc-f0b7-e053-2a95a90a2e12
Route
TOPICAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10.5 g)
Inactive Ingredients
Camphor, (-)- Menthol, Unspecified Form D&c Yellow No. 11 Paraffin Propylparaben Petrolatum Lanolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-01-21 Until 2027-07-01
Description

Active ingredient Purpose Methyl salicylate 10.5%....................External analgesic

Medication Information

Description

Active ingredient Purpose Methyl salicylate 10.5%....................External analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains
Section 51945-4

Section 55105-1

Active ingredient Purpose

Methyl salicylate 10.5%....................External analgesic

Warnings

For external use only. Avoid contact with the eyes.

Directions
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor
Do Not Use
  • on wounds or damaged skin
Other Information
  • store between 59-86°F (15-30°C)
  • do not use if seal over cap is broken, torn, or missing
Inactive Ingredients
  • camphor, D&C yellow #11, lanolin, menthol, paraffin, petrolatum, propylparaben
Questions Or Comments?

+1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com

When Using This Product
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
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 Center immediately.

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains
Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Active ingredient Purpose

Methyl salicylate 10.5%....................External analgesic

Warnings

For external use only. Avoid contact with the eyes.

Directions
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor
Do Not Use (Do not use)
  • on wounds or damaged skin
Other Information (Other information)
  • store between 59-86°F (15-30°C)
  • do not use if seal over cap is broken, torn, or missing
Inactive Ingredients (Inactive ingredients)
  • camphor, D&C yellow #11, lanolin, menthol, paraffin, petrolatum, propylparaben
Questions Or Comments? (Questions or comments?)

+1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com

When Using This Product (When using this product)
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
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 Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:28.288886 · Updated: 2026-03-14T23:10:57.415546