ORAL DENT AMBER- eucalyptol ,thymol, methyl salicylate, menthol  mouthwash 
International Cosmetic Limited

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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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

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

Inactive ingredients

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

Manufactured for

International Cosmetics Ltd.

ICL Drive, Bhagowtie Trace,

San Juan, Trinidad & Tobago, W.I.

INFO. CALL:1-868-675-2674 

Packaging

Oral dent carton

ORAL DENT  AMBER
eucalyptol ,thymol, methyl salicylate, menthol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66969-6012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.092 g  in 100 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.064 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.060 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.042 g  in 100 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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCARAMELImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66969-6012-21000 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/FEIBusiness Operations
International Cosmetics Ltd.857266290manufacture(66969-6012)

Revised: 3/2014
Document Id: a861cd9a-2d37-4861-8270-d8c30bb91e7c
Set id: c03068f0-61a9-4be0-be42-a870491a39d7
Version: 3
Effective Time: 20140315
 
International Cosmetic Limited