Chamosyn Ointment
FDA Label NDC 51028-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Links Medical Products for the product Chamosyn (NDC 51028-003). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

  • Menthol 0.45% or 0.1%
  • Zinc oxide 20%

Purpose

  • Anorectal analgesic/Anti-itch
  • Skin protectant

Uses

  • Helps relieve the local discomfort, burning, and itching of the perianal area associated with anorectal disorders and inflamed hemorrhoidal tissues.
    • Aids in protecting irritated anorectal areas.
      • Dries the oozing and weeping of poison
        • ivy
        • oak
        • sumac

Warnings

For external use only.

When using this product

  • do not get into eyes

    • Stop use and ask a doctor if

    • condition worsens
    • symptoms do not improve within 7 days or clear up and occur again within a few days.

      • Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any medical device or applicator. Certain persons can develop allergic reactions to this product. If symptoms do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with clean tissue or a clean soft cloth before application of this product.
  • Children under 12 years of age: consult a doctor.
  • Apply externally to the affected area as needed up to 6 times daily or after each incontinence episode or diaper change.

Other Information

Store between 59°-86°F (15°-30°C)

Inactive Ingredients

Chamosyn

Active aloe gel, Calamine, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Glycerin, Lanolin, Light mineral oil, Manuka honey, Methylparaben, Microcrystalline wax, Petrolatum, Propylparaben, Sodium borate, Sorbitan oleate, Tocopherol, Water

Chamosyn - Paraben Free

Active aloe gel, Calamine, Caprylyl glycol, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Ethylhexylglycerin, Glycerin, Lanolin, Light mineral oil, Manuka honey, Microcrystalline wax, Petrolatum, Phenoxyethanol, Sodium borate, Sorbitan oleate, Tocopherol, Water

Questions?

(888) 425-1149

Chamosyn Ointment (0.45% Menthol)

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Chamosyn Ointment (0.45% Menthol) - Paraben Free

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Chamosyn Ointment (0.1% Menthol)

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