EXODEN POWDER- cetylpyridinium chloride, domiphen bromide powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOMIPHEN BROMIDE (UNII: R4CY19YS7C) (DOMIPHEN - UNII:4AZL56CU0F), CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)

Available from:

LIFEON Corp.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral Health Care Provide better health to teeth and gums

Authorization status:

unapproved drug other

Summary of Product characteristics

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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70602-003_EXODEN POWDER
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
EXODEN POWDER
cetylpyridinium chloride, domiphen bromide powder
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70602-003
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
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
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENTONITE (UNII: A3N5ZCN45C)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENTHOL (UNII: BZ1R15MTK7)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
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 INFORMATION
MARKETING
CA