Calasoothe Ointment
FDA Label NDC 67777-241

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Calasoothe (NDC 67777-241). 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, stop use and ask a doctor if, when using this product, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Stop Use And Ask A Doctor If

→ When Using This Product

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Label 1271

→ Label 1273

→ Label 1275

Active Ingredient

Calamine USP 5%

Menthol USP 0.44%

Zinc Oxide USP 20.625%

Purpose

Skin Protectant

Anorectal Analgesic

Anorectal Astringent

Uses

• Dries the oozing and weeping of poison: • ivy •oak • sumac

• Helps relieve the itching and discomfort associated with anorectal disorders

• For the temporary relief of irritation and burning

• May provide a cooling sensation

Warnings

For external use only

Stop Use And Ask A Doctor If

• condition worsens or does not improve within 7 days, concult a doctor • bleeding occurs • redness, irritation, swelling, or pain develops or increases

When Using This Product

• Do not exceed the recommended daily dosage unless directed by a doctor • Certain people can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symtoms develop or increase, discontinue use and consult a doctor. • Do not put this product into the rectum by using fingers or any mechanical device or applicator

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily or after each bowel movement. • Children under 12 years of age: Consult a doctor