LAMRING COOL MINT- cetylpyridinium chloride spray

LAMRING COOL MINT by

Drug Labeling and Warnings

LAMRING COOL MINT by is a Otc medication manufactured, distributed, or labeled by EMAI TECHNOLOGY JAPAN CO.,LTD., Fulijaya Manufacturing Sdn. Bhd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Cetylpyridinium Chloride 0.05%

Purpose

Kills Germs & Bacterial

Use

After opening thelid, aim the spray nozzleat the open mouth, andpress thé nozzle naturallyto the end to ensure thatthe spray is pumped intothe mouth, and there isno need to gargle waterwithin half an hour.

Warnings

Do not use this product if gums areirritated or bleeding unless directed to do so bya doctor ordentistIfmore than twice the recommended amountfor tongue spraying is accidentally swallowedgetmedical help ör contact a Poison controlCenterimmediately.oodevare a one hesnixsersco era?Do not spray into '

DO NOT USE

Directions

Shake befor use. Adults and children 12 years of ages and older.Spray 3times in the oral cavity.Children 6-12years of age:Supervise use.Children under 6 years:Do not use

STOP USE

Caution

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

STORAGE AND HANDLING

Inactive ingredients

Water(Aqua),Sorbitol,Glycerin,Xylitol,Peg-40 Hydrogenated Castor Oil,Aroma(Flavour),BenzoicAcid,Sodium Benzoate,Sodium  Saccharin,CI 14720

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LAMRING COOL MINT 
cetylpyridinium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84605-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84605-001-01	1 in 1 PACKAGE	07/31/2024
1		20 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	07/31/2024

Labeler - EMAI TECHNOLOGY JAPAN CO.,LTD. (718100206)

Registrant - EMAI TECHNOLOGY JAPAN CO.,LTD. (718100206)

Establishment
Name	Address	ID/FEI	Business Operations
Fulijaya Manufacturing Sdn. Bhd		652087115	manufacture(84605-001)