FDA.reportPublic FDA data

Shopko Alcohol Free Multi Action

Manufacturer
Apollo Health and Beauty Care Inc.
Effective date
2018-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:50

Label at a glance#

ProductShopko Alcohol Free Multi Action
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure8 sections

Indications and uses

helps reduce plaque that lead to: gingivitis bleeding gums

Dosage and administration

Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Children 6 years to under 12 years of age: supervise use. Children under 6 years of age: do not use.

Storage and handling

this rinse is not intended to replace brushing or flossing. store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

  • helps reduce plaque that lead to:
  • gingivitis
  • bleeding gums

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • Children 6 years to under 12 years of age: supervise use.
  • Children under 6 years of age: do not use.

Other information

STORAGE AND HANDLING SECTION

  • this rinse is not intended to replace brushing or flossing.
  • store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions ro comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN1
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD1
1100924cetylpyridinium chloride 0.07 % Oral RinseSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-010-322024-01-30C16284748780-11030e365-24a0-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-010-32Shopko Alcohol Free Multi Action946 mL in 1 BOTTLE, PLASTICMOUTHWASH9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-010SHOPKO ALCOHOL FREE MULTI ACTION (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20180609_2d867d6c-d9f9-4ee4-8221-34b1ad870fd8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-01063148-010-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
METHYLPARABENA2I8C7HI9TIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLPARABENZ8IX2SC1OHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
23452743-c997-4775-843d-7ff5f35172c32d867d6c-d9f9-4ee4-8221-34b1ad870fd82018-06-08WarningsExact identifier
spl id: 23452743-c997-4775-843d-7ff5f35172c3
spl set id: 2d867d6c-d9f9-4ee4-8221-34b1ad870fd8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.