70602-003_Exoden Powder

EXODEN POWDER- cetylpyridinium chloride, domiphen bromide powder
LIFEON Corp.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Cetylpyridinium Chloride(CPC) 0.43%
Domiphen Bromide 0.120

Oral Health Care

Provide better health to teeth and gums

Wet your toothbrush, shake off surplus water and press into powder. Brush teeth thoroughly and rinse

Ask a dentist before use if you have
• bleeding or redness lasting more than 2 weeks
• pain, swelling, pus, loose teeth, or more spacing between teeth
These may be signs of periodontitis, a serious form of gum disease

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Bentonite, Sodium Chloride(Bamboo Salts), L-Menthol

image description

EXODEN POWDER
cetylpyridinium chloride, domiphen bromide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70602-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOMIPHEN BROMIDE (UNII: R4CY19YS7C) (DOMIPHEN - UNII:4AZL56CU0F)	DOMIPHEN BROMIDE	0.12 in 100 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.043 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BENTONITE (UNII: A3N5ZCN45C)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENTHOL (UNII: BZ1R15MTK7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70602-003-02	1 in 1 CARTON	03/09/2021
1	NDC:70602-003-01	10 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:70602-003-04	1 in 1 CARTON	03/09/2021
2	NDC:70602-003-03	30 g in 1 CONTAINER; Type 0: Not a Combination Product
3	NDC:70602-003-06	1 in 1 CARTON	03/09/2021
3	NDC:70602-003-05	70 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/09/2021

Labeler - LIFEON Corp. (688528872)

Registrant - LIFEON Corp. (688528872)

Name	Address	ID/FEI	Business Operations
Establishment
Korea Shidenta		688171734	manufacture(70602-003)