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Oral Dent Amber by International Cosmetics Ltd.

Medically reviewed on March 13, 2018

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 Cosmetics Ltd.
NDC Code: 66969-6020

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 Amber


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 20%, Benzoic Acid, Poloxamer 407, Sodium Benzoate and Caramel.

Manufactured by

International Cosmetics Ltd.

ICL Drive, Bhagowtie Trace,

San Juan, Trinidad & Tobago, W.I.

INFO. CALL:1-868-675-2674 

Packaging

ORAL DENT  AMBER
eucalyptol, thymol, methyl salicylate, menthol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66969-6020
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 
BENZOIC ACID 
POLOXAMER 407 
SODIUM BENZOATE 
CARAMEL 
Product Characteristics
Color    Score    
ShapeSize
FlavorCARAMELImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:66969-6020-0500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/10/2013
Labeler - International Cosmetics Ltd. (857266290)
Establishment
NameAddressID/FEIOperations
International Cosmetics Ltd.857266290manufacture(66969-6020)

 
International Cosmetics Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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