BUENOS DIAS DE PERSONNA COOL MINT- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Buenos Dias de Personna by

Drug Labeling and Warnings

Buenos Dias de Personna by is a Otc medication manufactured, distributed, or labeled by International Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (W/V)

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

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 (590-860 F)
Do not use if security band around cap is missing or broken

Inactive ingredients

Water, Alcohol 21.6%, Sorbitol Solution, Poloxamer 407, Benzoic Acid, Sodim Benzoate ,Flavour, Sodium Saccharin and  FD&C Green  No.3.

Distributed By

2011 Energiser Personal Care LL
dba Personna International of PR
#36 Carr 20 Kim 2.2 Suite 203, Guaynabo PR00966
787-761-9500
Made in Trinidad & Tobago,W.I.

Packaging

INGREDIENTS AND APPEARANCE

BUENOS DIAS DE PERSONNA  COOL MINT
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66969-6003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.092 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.042 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.060 g  in 100 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.064 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66969-6003-3	1000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/10/2013

Labeler - International Cosmetics Ltd. (857266290)

Establishment
Name	Address	ID/FEI	Business Operations
International Cosmetics Ltd.		857266290	manufacture(66969-6003)