Label: PHYLORINOL liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54061-101-01 - Packager: Schaffer Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 25, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Label
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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.
- OTC - PURPOSE SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- INDICATIONS & USAGE SECTION
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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.
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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
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Children under 6 years of age: consult a dentist or doctor
- INACTIVE INGREDIENT SECTION
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INGREDIENTS AND APPEARANCE
PHYLORINOL
phylorinol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54061-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL .25 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 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)