WARNINGS AND PRECAUTIONS SECTION

Children of six years and younger: Use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources, consult a dentist or doctor.

Direction

Brush thoroughly, preferably after each meal or at least twice a day. Do not swallow. Rinse and spit out after use.

Warning

Keep out of reach of children

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Sodium Saccharin, Methylparaben, Mica, Propylparaben, FD&C Red No.40

Active Ingredient

Sodium Monofluorophosphate:
1.14% w/w (1,500 ppm fluoride as added)
(0.15% w/w fluoride ion)

Use

Helps protect against cavities

Anti-cavity

PRODUCT SPECIFICATIONS

HAPEE EXPLOSIVE MENTHOL RED 150

EXPLOSIVE_MENTHOL_RED_150_ML

HAPEE FRESH AND COOL WHITE 150 ML

FRESH_AND_COOL_WHITE_150ML

HAPEE FRESH AND COOL WHITE 100ML

FRESH_AND_COOL_WHITE_100_ML

HAPEE GUMTECT GUM CARE

HAPEE GUMTECT SENSITIVE 150

GUMTECT_SENSITIVE

HAPEE FRESH GREEN OUTBURST 100ML

FRESH_GREEN_OUTBURST_100ML

HAPEE FRESH GREEN OUTBURST 150 ML

FRESH_GREEN_OUTBURST_150ML

HAPEE OUTRSGEOUS BLUE CHILL

OUTRAGEOUS_BLUE_CHILL_150_ML

HAPEE EXPLOSIVE MENTHOL RED 150
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82426-150
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICA (UNII: V8A1AW0880)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	MENTHOL (Characteristic, sweet spicy taste)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82426-150-01	1 in 1 CARTON	05/20/2022
1		189 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/20/2022

HAPEE FRESH AND COOL WHITE 150
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82426-151
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MENTHOL (Methanol and spearmint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82426-151-01	1 in 1 CARTON	05/27/2022
1		205.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/20/2022

HAPEE FRESH AND COOL WHITE 100
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82426-152
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MENTHOL (Methanol and spearmint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82426-152-01	1 in 1 CARTON	05/27/2022
1		138 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/20/2022

HAPEE GUMTECT GUM CARE
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82426-153
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
ALLANTOIN (UNII: 344S277G0Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MENTHOL (Rich, rounded spearmint with fresh mentholic peppermint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82426-153-01	1 in 1 CARTON	05/20/2022
1		151 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/20/2022

HAPEE GUMTECT SENSITIVE 100
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82426-154
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.331 g in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALLANTOIN (UNII: 344S277G0Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MENTHOL (Characteristic, sweet minty taste)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82426-154-01	1 in 1 CARTON	05/27/2022
1		133 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/20/2022

HAPEE FRESH GREEN OUTBURST 100
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82426-155
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CELLULOSE SODIUM PHOSPHATE (UNII: E6S1NJ4Y5Q)
MICA (UNII: V8A1AW0880)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MENTHOL (Sweet spicy taste)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82426-155-01	1 in 1 CARTON	05/27/2022
1		128 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/20/2022

HAPEE FRESH GREEN OUTBURST 150
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82426-156
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CELLULOSE SODIUM PHOSPHATE (UNII: E6S1NJ4Y5Q)
MICA (UNII: V8A1AW0880)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MENTHOL (Sweet spicy taste)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82426-156-01	1 in 1 CARTON	05/27/2022
1		192 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/20/2022

HAPEE OUTRAGEOUS BLUE CHILL 150
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82426-157
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MICA (UNII: V8A1AW0880)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MENTHOL (sweet spicy taste)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82426-157-01	1 in 1 CARTON	05/27/2022
1		192 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/20/2022

Labeler - LAMOIYAN CORPORATION (718765928)

Name	Address	ID/FEI	Business Operations
Establishment
LAMOIYAN CORPORATION		718765928	manufacture(82426-150, 82426-151, 82426-152, 82426-153, 82426-154, 82426-155, 82426-156, 82426-157)