SPL v1
SPL
SPL Set ID 3afe387c-ef42-215d-e063-6394a90a41b5
Route
TOPICAL
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (0.5 g)
Inactive Ingredients
Water Cetostearyl Alcohol Menthol, Unspecified Form Imidurea Glycol Stearate Mineral Oil Ethylhexylglycerin Peg-40 Castor Oil Carbomer Homopolymer, Unspecified Type Phenoxyethanol Petrolatum Sodium Hydroxide Sodium Cetostearyl Sulfate Dimethicone, Unspecified Propylene Glycol Stearic Acid Titanium Dioxide Edetate Disodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-15
Description

Camphor 0.5%

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Camphor 0.5%

Uses

Uses

For the temporary relief of pain and itching associated with: nsect bites, minor cuts, minor burns, sunburn, scrapes, minor skin irritations, rashes due to poison ivy, poison oak, or poison sumac

Section 51945-4

Warnings

Warnings

For external use only

Directions

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 physician
Active Ingredient

Camphor 0.5%

Inactive Ingredients

Inactive Ingredients

Carbomer, Cetostearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Imidurea, Glycol Stearate, Menthol, Mineral Oil, PEG-40 Castor Oil, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Cetostearyl Sulfate, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Water

When Using This Product

When using this product avoid contact with the eyes

Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Structured Label Content

Uses

Uses

For the temporary relief of pain and itching associated with: nsect bites, minor cuts, minor burns, sunburn, scrapes, minor skin irritations, rashes due to poison ivy, poison oak, or poison sumac

Section 51945-4 (51945-4)

Purpose

External Analgesic

Warnings

Warnings

For external use only

Directions

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 physician
Active Ingredient

Camphor 0.5%

Inactive Ingredients

Inactive Ingredients

Carbomer, Cetostearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Imidurea, Glycol Stearate, Menthol, Mineral Oil, PEG-40 Castor Oil, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Cetostearyl Sulfate, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Water

When Using This Product (When using this product)

When using this product avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:00.157511 · Updated: 2026-03-14T23:10:09.220745