PerioRinse by CENTURA PHARMACEUTICALS INC

PerioRinse by

Drug Labeling and Warnings

PerioRinse by is a Otc medication manufactured, distributed, or labeled by CENTURA PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PERIORINSE- dyclonine rinse 
CENTURA PHARMACEUTICALS INC

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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ACTIVE INGREDIENT

Dyclonine 0.10%

PURPOSE

Anesthetic/Analgesic

USES

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

WARNINGS

Severe or persistent sore throat or sore throat accompanied by high fever, headache,
nausea, and vomiting may be serious. Consult dentist or doctor promptly.
Do not use more than 2 days or administer to children under 3 years of age unless
directed by a dentist or doctor.
Discontinue use and consult a dentist or doctor if irritation persists or increases, or
a rash appears or you are allergic to this product.
Try to avoid swallowing this product.
If large quantity is accidentally swallowed, get medical help or contact a Poison
Control Center right away.
Keep out of reach of children.
If pregnant or breast-feeding, consult a dentist or doctor before use.

DIRECTIONS

Children 3-12 years of age - Vigorously swish and spit with 5ml to 10ml (1 to 2
teaspoonful’s) not more than three to four times a day. Try to avoid swallowing.
Adults and children over 12 years of age - Vigorously swish and spit with 10ml to 20ml
(2 to 4 teaspoonful’s) not more than three to four times a day. Try to avoid swallowing.

OTHER INFORMATION

Store at room temperature.

INACTIVE INGREDIENTS

Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Glycerin, Glycyrrhiza Glabra (Licorice)
Extract, Hydrastis Canadensis (Golden Seal) Extract, Cherry Flavor, Potassium Sorbate,
Sodium Benzoate, Stevia.

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABELING

LABEL

PERIORINSE 
dyclonine rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70372-726
Route of AdministrationORAL, TOPICAL, DENTAL, TRANSMUCOSAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
CHERRY (UNII: BUC5I9595W)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEVIA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70372-726-01480 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/16/201607/31/2018
Labeler - CENTURA PHARMACEUTICALS INC (084921637)
Registrant - CENTURA PHARMACEUTICALS INC (084921637)

Revised: 2/2020