ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Cariba International

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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Antiseptic Mouthrinse
318.003-318AH-AI

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

Helps control plaque that leads to gingivitis

Warnings

for this product

Do not use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of children

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

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

Other information

cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59° - 77°F) 

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Adverse reactions

Distributed by:

Cariba International

P.O. Box 1208

Safety Harbor, Florida 34695

MADE IN USA WITH US AND FOREIGN COMPONENTS

Principal display panel

Sealed with Printed Neckband for your Protection

CARIBA

ANTISEPTIC

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

ORIGINAL

Kills germs that cause Bad Breath,

Plaque & the gum disease Gingivitis

250 mL (8.5 FL OZ)

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67860-318
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67860-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/07/2016
2NDC:67860-318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/07/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/07/2016
Labeler - Cariba International (049354067)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(67860-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(67860-318)

Revised: 6/2023
Document Id: 239f937c-dc9e-4d34-9f20-2f244117c27b
Set id: 98471185-3798-412f-b9b4-47f1971fbc7c
Version: 11
Effective Time: 20230607
 
Cariba International