Phylorinol
FDA Label NDC 54061-101
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 Section Quick Index
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.
- severe or persists more than 2 days
- accompanied by :
- rash
- swelling
- fever
- headache
- nausea
- vomiting
- sore mouth symptoms do not improve in 7 days.
- irritation, pain, or redness persists or worsens
- 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
- store at 15o-30oC (59o-86oF)
Warnings
If used for sore throat:
Consult a doctor promplty if sore throat is
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
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
Other information
Inactive ingredients
boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.
Otc - Purpose Section
Otc - Keep Out Of Reach Of Children Section
Indications & Usage Section
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
- sore mouth symptoms do not improve in 7 days.
- irritation, pain, or redness persists or worsens
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
Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.
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
Inactive Ingredient Section
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