BUENOS DIAS DE PERSONNA COOL MINT- eucalyptol, menthol, methyl salicylate, thymol mouthwash
International Cosmetics Ltd.

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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Buenos Dias de Personna cool mint

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

Personna Cool mint

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - International Cosmetics Ltd. (857266290)

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