E ENZYME: Package Insert and Label Information

E ENZYME — sodium monofluorophosphate paste, dentifrice
SAMJOKO SKYBLUE 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.

Active ingredient: SODIUM MONOFLUOROPHOSPHATE 0.6%

Inactive ingredients:

Water, D-Sorbitol Liquefied, Colloidal Silcon Dioxide, ATTAPULGITE, PEG-1500, Sluminum chlorohydroxg allautonate, Aminocaparoid Acid, Sodium Saccharine, XYLITOL, Butyl-P oxybenzoare, Hydroxyapatite, Carbon hydrozen Sodium, GLYCERIN, Carboxymethylcellulose nattrium, Sulfuricacid, GRAPEFRUIT SEED OIL, GREEN TEA LEAF, PROPOLIS WAX, I-mentol, Optimint

Purpose: Anticavity, remove plaque, bad breath, whiten tooth — it improved taste keeps mouth feeling fresh and clean.

Warnings:
It includes fluoride 792ppm
Children under 6 years of age: use a pea-size amount. Do not swallow. Supervis children’s brushing until capable of using without supervision.
If children accidentally swallow more than used for brushing, ask a dentist or physician.

Keep out of reach of children:

Keep out of reach of children.

Indication and usage:
Aids in the prevention of cavities
Helps prevent gingivitis and alveolar pyorrhea

Dosage and administration:
Adults at least a half-inch strip of the product onto a soft bristled tooth brush.
Brush teeth thoroughly for at least 3 minutes twice a day.

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E ENZYME
sodium monofluorophosphate paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76414-010
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 1.2 g in 200 g
Inactive Ingredients
Ingredient Name Strength
Water
ATTAPULGITE
XYLITOL
GLYCERIN
GRAPEFRUIT SEED OIL
GREEN TEA LEAF
PROPOLIS WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76414-010-01 200 g in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 03/01/2011
Labeler — SAMJOKO SKYBLUE CO., LTD. (557804810)
Registrant — SAMJOKO SKYBLUE CO., LTD. (557804810)
Establishment
Name Address ID/FEI Operations
SAMJOKO SKYBLUE CO., LTD. 557804810 manufacture

Revised: 11/2011 SAMJOKO SKYBLUE CO., LTD.

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