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ORAL-DENT Blue Mint by International Cosmetic Limited

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.092g in 100mL, THYMOL 0.064g in 100mL, METHYL SALICYLATE 0.060g in 100mL, MENTHOL 0.042g in 100mL
Labeler: International Cosmetic Limited
NDC Code: 66969-6014

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.

Oral Dent Blue Mint


Active ingredients (W/V)

Eucalyptol 0.092%
Thymol 0.064%
Methyl Salicylate 0.060%
Menthol 0.042%

Purpose

Antiplaque/Antigingivitis

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

Helps kill germs that cause plaque, gingivitis and bad breath.

Warnings
  • Do not swallow 
  • Not to be used by children under 12 years of age 

Directions

Rinse Full Strength with 2/3 ounce (20 ml) for 30 seconds twice a day to help kill germs that cause bad breath, plaque and gingivitis.

Other information
  • Cold temperature may cloud this product; its efficacy will not be affected. Store at room temperature (590-86F)
  • Do not use if security band around cap is missing or broken

Inactive ingredients

Water, Alcohol (15%), Sorbitol Solution, Poloxamer 407, Benzoic Acid, Flavour, Sodium Saccharin, Sodium Citrate, Citric acid, D&C Yellow No.10, FD&C Green No. 3.

Manufactured for

International Cosmetics Ltd.

ICL Drive, Bhagowtie Trace,

San Juan, Trinidad & Tobago, W.I.

INFO. CALL:1-868-675-2674 

Packaging

ORAL-DENT  BLUE MINT
eucalyptol, thymol, methyl salicylate, menthol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66969-6014
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.092 g  in 100 mL
THYMOL (THYMOL) THYMOL0.064 g  in 100 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.060 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL0.042 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM CITRATE 
CITRIC ACID MONOHYDRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:66969-6014-41000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/10/2013
Labeler - International Cosmetic Limited (857266290)
Establishment
NameAddressID/FEIOperations
International Cosmetic Limited857266290manufacture(66969-6014)

Revised: 03/2014
 
International Cosmetic Limited

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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