SHOPKO ALCOHOL FREE MULTI ACTION- cetylpyridinium chloride mouthwash 
Apollo Health and Beauty Care 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.

----------

Drug Facts

Active ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis/Antiplaque

Uses

Warnings

Stop use and ask a dentist if

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

If more than used for rinsing is accidentally swalowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

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

Questions ro comments?

1-866-695-3030

Label Copy

Image of the label

SHOPKO ALCOHOL FREE MULTI ACTION 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-010
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:63148-010-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/07/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/07/2018
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(63148-010)

Revised: 6/2018
Document Id: 23452743-c997-4775-843d-7ff5f35172c3
Set id: 2d867d6c-d9f9-4ee4-8221-34b1ad870fd8
Version: 1
Effective Time: 20180608
 
Apollo Health and Beauty Care Inc.