SARINA ANTISEPTIC- chlorhexidine digluconate liquid 
Sarina Accessories, LLC

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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SARINA ANTISEPTIC MOUTHWASH

Active ingredients

Cetylpyridinium Chloride 0.1%.

Purpose

Antiplaque

Use

Helps reduce plaque that leads to

Warnings

Stop use and see your dentist immediately if

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

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 agesupervise use
children under 6 years of agedo not use

Other information

Inactive ingredients

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

image of bottle label

SARINA  ANTISEPTIC
chlorhexidine digluconate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90106-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90106-003-0190 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/25/2020
Labeler - Sarina Accessories, LLC (787043145)

Revised: 8/2020
Document Id: adaa3f3c-b3cb-aa87-e053-2995a90ad2f0
Set id: adaa2660-a390-9d1f-e053-2995a90abd67
Version: 1
Effective Time: 20200825
 
Sarina Accessories, LLC