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

Warnings

For external use only. Avoid contact with the eyes.

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
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
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
Description

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

Section 51945-4

Section 55105-1

Active ingredient Purpose

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

Do Not Use
  • on wounds or damaged skin
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

Warnings

For external use only. Avoid contact with the eyes.

Uses

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

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

Section 55105-1 (55105-1)

Active ingredient Purpose

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

Do Not Use (Do not use)
  • on wounds or damaged skin
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

Back to search View SPL set listing Open on DailyMed ↗

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