QUALITY CHOICE MINT- cetylpryidinium chloride liquid 
CHAIN DRUG MARKETING ASSOCIATION INC

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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Active ingredients

Cetylpyridinium Chloride 0.07%

Purpose

Antiplaque/Antigingivitis

Uses

Warnings

Ask dentist if symptoms persist or condition worsens after regular use.

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Directions

Other information

Store at room temperature

Inactive ingredients

Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090)

Questions or comments?

1-248-449-9300

Label Copy

Image of the label

QUALITY CHOICE MINT 
cetylpryidinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-553
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-553-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/13/2015
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(63868-553)

Revised: 9/2015
Document Id: 8e0c8f4e-b872-4c2b-b4d4-b3700b55fba5
Set id: beb24f57-87d5-4c86-9de4-09766ccc57d9
Version: 1
Effective Time: 20150914
 
CHAIN DRUG MARKETING ASSOCIATION INC