SARINA ANTISEPTIC- chlorhexidine digluconate liquid

SARINA by

Drug Labeling and Warnings

SARINA by is a Otc medication manufactured, distributed, or labeled by Sarina Accessories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Cetylpyridinium Chloride 0.1%.

Purpose

Antiplaque

Use

Helps reduce plaque that leads to

• ginivitis
• bleeding gums

Warnings

Stop use and see your dentist immediately if

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth.

These may be signs or symptoms of periodontitis, a serious form of gum disease.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• adults and children 12 years of age and older:

  vigorously swish 20 milliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse

• children 6 to 12 years of age: supervise use
• children under 6 years of age: do not use

Other information

• not intended to replace brushing or flossing
• store at room temperature (59°-77°F).
• cold weather may cloud this product, but will not affect its antiseptic properties.

Inactive ingredients

Water, Alcohol, PEG-60 Hydrogenated Castor Oil，Glycerin，Fragrance，Sodium Benzoate，Mentholum，Sodium Saccharin，Citric Acid，FD&C Blue No.1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SARINA  ANTISEPTIC
chlorhexidine digluconate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90106-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALCOHOL (UNII: 3K9958V90M)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90106-003-01	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/25/2020

Labeler - Sarina Accessories, LLC (787043145)