Duble X Concentration Gargle Liquid: Package Insert and Label Information

DUBLE X CONCENTRATION GARGLE LIQUID- cetylpyridinium chloride paste
DONG IL PHARMS CO.,LTD

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.

Cetylpyridinium Chloride

Mouth is clear and cool

Plaque removal

Oral cleanliness

Oral bad breath removal

Keep out of reach of children

Three times a day, add 5 drops of this solution to the enclosed cup, add water to the marked line, gargle for about 30 seconds, and spit it out.

  • Do not store above 30 ℃.
  • Avoid exposure to heat, sparks and sparks.
  • Be careful as it may irritate the eyes.
  • In case of contact with eyes, rinse with water.
  • Keep out of reach of babies and young children.

Water, Sorbitol, Flavor, Propolis Wax, Gardenia Blue Color, Chitosan, Citrus Grandis (Grapefruit) Seed Extract, Xylitol, Curcuma , Xanthorrhiza Root Extract, Stevioside, Taraxacum Platycarpum Extract, Camellia Sinensis Leaf Extract

For dental use only

label
(click image for full-size original)

DUBLE X CONCENTRATION GARGLE LIQUID
cetylpyridinium chloride paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73242-0102
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 2.296 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
XYLITOL
Product Characteristics
Color blue Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73242-0102-1 50 mL in 1 BOTTLE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 12/10/2019
Labeler — DONG IL PHARMS CO.,LTD (557810721)
Registrant — DONG IL PHARMS CO.,LTD (557810721)
Establishment
Name Address ID/FEI Operations
DONG IL PHARMS CO., LTD. 557810721 manufacture (73242-0102)

Revised: 01/2020 DONG IL PHARMS CO.,LTD

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