3afe387c-ef42-215d-e063-6394a90a41b5

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
Purpose

External Analgesic

Description

Camphor 0.5%

Medication Information

Warnings

Warnings

For external use only

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

Purpose

External Analgesic

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
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

Description

Camphor 0.5%

Section 51945-4

Active Ingredient

Camphor 0.5%

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

Warnings

Warnings

For external use only

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

Purpose

External Analgesic

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
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

Section 51945-4 (51945-4)

Active Ingredient

Camphor 0.5%

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