Dermasarra
FDA Label NDC 61924-189

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermarite Industries, Llc for the product Dermasarra (NDC 61924-189). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, warnings, directions:, other infomation:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Camphor 0.5%

Purpose

External Analgesic

Uses:

Temporary relief of itching associiated with minor skin irritations due to:

  • dry skin
  • insect bites
  • detergent
  • sunburn

Warnings:

  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days, symptoms clear up and occur again within a few days
  • Do not use on deep puncture wounds, animal bites, or serious burns.

Warnings

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

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times dialy,

Children under 2 years of age: Consult a doctor

Other Infomation:

Store at room temperature (59°-86°F)

You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

water, Cetearyl Alcohol, PEG-40 Castor Oil, Sodium Cetearyl Sulfate, Stearic Acid, Glycol Stearate, Mineral Oil, Dimethicone, PEG-4 Dilaurate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Titanium Dioxide, menthol, Carbomer, Petrolatum, Disodium EDTA

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