Recticare Cloth
FDA Label NDC 0496-0980

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ferndale Laboratories, Inc. for the product Recticare (NDC 0496-0980). 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, do not, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 5% w/w

Glycerin 20% w/w

Purpose

Lidocaine 5% w/w........................................Local anesthetic

Glycerin 20% w/w.........................................Protectant

Uses

  • helps relieve the pain, itching and burning associated with anorectal disorders
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects irritated and inflamed perianal skin

Warnings

For external use only

Do Not

  • exceed the recommended daily dosage unless directed by a doctor
  • put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • an allergic reaction develops
  • condition worsens or does not improve witin 7 days
  • redness, irriation, swelling, pain or other symptoms begin or increase
  • bleeding occurs

Otc - Keep Out Of Reach Of Children

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

Directions

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroghly
  • gently apply wipe to the affected area by patting and then discard
  • adults and children 12 years & older: apply up to 6 times daily - or after each bowel movement
  • children under 12 years: consult a doctor

Inactive Ingredients

benzyl alcohol, citric acid, purified water

Package Label

Frontpouch (Frontpouch)

Frontpouch (Frontpouch)

Pouchback (Pouchback)

Pouchback (Pouchback)

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