Your browser does not support JavaScript! PHYLORINOL LIQUID [SCHAFFER LABORATORIES]
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PHYLORINOL liquid
[Schaffer Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Label

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

OTC - PURPOSE SECTION

Uses

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

Label

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

INDICATIONS & USAGE SECTION

Other information

  • store at 15o-30oC (59o-86oF)

Label

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

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

Label

PHYLORINOL 
phylorinol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54061-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL.25 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54061-101-01237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/05/2014
Labeler - Schaffer Laboratories (018440696)
Registrant - Schaffer Laboratories (018440696)
Establishment
NameAddressID/FEIBusiness Operations
Schaffer Laboratories018440696manufacture(54061-101)

Revised: 3/2014
 
Schaffer Laboratories

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