Label: PHYLORINOL- phenol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • Label
  • 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

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  • OTC - PURPOSE SECTION

    Uses

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

    Label

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  • 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

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  • INDICATIONS & USAGE SECTION

    Other information

    • store at 15o-30oC (59o-86oF)

    Label

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  • 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

    Close
  • 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

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  • INACTIVE INGREDIENT SECTION

    Inactive ingredients

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

    Label

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  • INGREDIENTS AND APPEARANCE
    PHYLORINOL 
    phylorinol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54061-101
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENOL (PHENOL) PHENOL .25 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Product Characteristics
    Color green Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54061-101-01 237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 03/05/2014
    Labeler - Schaffer Laboratories (018440696)
    Registrant - Schaffer Laboratories (018440696)
    Establishment
    Name Address ID/FEI Business Operations
    Schaffer Laboratories 018440696 manufacture(54061-101)
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