Phylorinol
FDA Label NDC 54061-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schaffer Laboratories for the product Phylorinol (NDC 54061-101). 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 label, otc - active ingredient section, otc - purpose section, otc - keep out of reach of children section, indications & usage section, warnings section, dosage & administration section, inactive ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label

Label (Phylorinol)

Label (Phylorinol)

Otc - Active Ingredient Section

Drug Facts

Active Ingredient

Phenol 0.6%...............Oral Pain Reliever

Uses

  • temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.
  • Warnings

    If used for sore throat:

    Consult a doctor promplty if sore throat is

    • severe or persists more than 2 days
    • accompanied by :
    • rash
    • swelling
    • fever
    • headache
    • nausea
    • vomiting
    • Unless directed by a doctor do not administer to children under 3 years of age.

      If used for sore mouth:

      See your dentist or doctor promptly if

      • sore mouth symptoms do not improve in 7 days.
      • irritation, pain, or redness persists or worsens
      • Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.

        Keep out of reech of children.

        If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away.

        Directions

        • Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor.
        • Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.
        • Children under 6 years of age: consult a dentist or doctor
        • Other information

          • store at 15o-30oC (59o-86oF)
          • Inactive ingredients

            boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

            Label (Phylorinol)

            Label (Phylorinol)

Otc - Purpose Section

Uses

  • temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.
  • Label (Phylorinol)

    Label (Phylorinol)

Otc - Keep Out Of Reach Of Children Section

Keep out of reech of children.

If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Label (Phylorinol)

Label (Phylorinol)

Indications & Usage Section

Other information

  • store at 15o-30oC (59o-86oF)
  • Label (Phylorinol)

    Label (Phylorinol)

Warnings Section

Warnings

If used for sore throat:

Consult a doctor promplty if sore throat is

  • severe or persists more than 2 daysaccompanied by :
  • rash
  • swelling
  • fever
  • headache
  • nausea
  • vomiting
  • Unless directed by a doctor do not administer to children under 3 years of age.

    If used for sore mouth:

    See your dentist or doctor promptly if

    • sore mouth symptoms do not improve in 7 days.
    • irritation, pain, or redness persists or worsens
    • Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.

      Label (Phylorinol)

      Label (Phylorinol)

Dosage & Administration Section

Directions

  • Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor.
  • Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.Children under 6 years of age: consult a dentist or doctor
  • Children under 6 years of age: consult a dentist or doctor

  • Label (Phylorinol)

    Label (Phylorinol)

Inactive Ingredient Section

Inactive ingredients

boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Label (Phylorinol)

Label (Phylorinol)

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