PHYLORINOL- phenol liquid 
Schaffer Laboratories

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.

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Label

Label

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient

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

Uses

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.

Label

OTC - PURPOSE SECTION

Uses

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

Label

WARNINGS SECTION

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.

Label

DOSAGE & ADMINISTRATION SECTION

Directions

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
Document Id: 6ee89110-ae7c-4814-a8f7-5cafa703741f
Set id: f643f019-4fdf-4bca-a5f1-7e8b4e171572
Version: 7
Effective Time: 20140325
 
Schaffer Laboratories