Kofal Original Blue 4 Oz (wp)(da)

Kofal Original Blue 4 Oz (wp)(da)
SPL v7
SPL
SPL Set ID 984780fd-496b-150b-e053-2995a90aed77
Route
TOPICAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (12 g)
Inactive Ingredients
Polysorbate 20 Glyceryl Monostearate Propylparaben Water Trolamine Methylparaben Paraffin Eucalyptus Oil Menthol, Unspecified Form Stearic Acid Camphor, (-)- Cetostearyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-12-03 Until 2027-07-01
Description

Active ingredient Purpose Methyl salicylate 12%...........................External analgesic

Medication Information

Description

Active ingredient Purpose Methyl salicylate 12%...........................External analgesic

Uses

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

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

Section 55105-1

Active ingredient Purpose

Methyl salicylate 12%...........................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, cetostearyl alcohol, eucalyptus oil, glyceryl monostearate, menthol, methylparaben, paraffin, polysorbate 20, propylparaben, stearic acid, trolamine, water

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
  • bruises
  • sprains
Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Active ingredient Purpose

Methyl salicylate 12%...........................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, cetostearyl alcohol, eucalyptus oil, glyceryl monostearate, menthol, methylparaben, paraffin, polysorbate 20, propylparaben, stearic acid, trolamine, water

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: 2026-02-15T12:07:28.283359 · Updated: 2026-03-14T23:10:57.415546