drug Facts

drug Facts
SPL v3
SPL
SPL Set ID 9e3077f7-4181-4e35-8ec7-2065f555a7b8
Route
TOPICAL
Published
Effective Date 2013-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (1.7 mg) Menthol (0.7 mg) Phenol (0.4 mg)
Inactive Ingredients
Alum, Potassium White Wax Cocoa Butter Lanolin Petrolatum Salicylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-30
Description

Camphor, 1.7% Menthol, 0.7% Phenol, 0.4%

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Camphor, 1.7% Menthol, 0.7% Phenol, 0.4%

Section 50565-1
Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop use and ask a doctor

  • if rash occurs
  • symptoms last for more than 7 days or clear up and occur agin within a few days
Section 50567-7

When using this product  keep out of eyes.  Rinse with water to remove.

Section 51945-4

uses
  • temporarily relieves pain and itching commonly associated with fever blisters and cold sores
purpose

External Analgesic

warnings

For external use only

directions
  • adults and children 2 years of age and older, apply to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Active Ingredients

Camphor, 1.7%

Menthol, 0.7%

Phenol, 0.4%

inactive Ingredients

Alum, beeswax, cocoa butter, flavor, lanolin, petrolatum, salicylic acid

Structured Label Content

Section 50565-1 (50565-1)
Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor

  • if rash occurs
  • symptoms last for more than 7 days or clear up and occur agin within a few days
Section 50567-7 (50567-7)

When using this product  keep out of eyes.  Rinse with water to remove.

Section 51945-4 (51945-4)

uses (Uses)
  • temporarily relieves pain and itching commonly associated with fever blisters and cold sores
purpose (Purpose)

External Analgesic

warnings (Warnings)

For external use only

directions (Directions)
  • adults and children 2 years of age and older, apply to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Active Ingredients (Active ingredients)

Camphor, 1.7%

Menthol, 0.7%

Phenol, 0.4%

inactive Ingredients (Inactive ingredients)

Alum, beeswax, cocoa butter, flavor, lanolin, petrolatum, salicylic acid

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:42.956450 · Updated: 2026-03-14T22:53:37.408704