Drug Facts

Active Ingredient

SODIUM FLUORIDE 0.243% (0.13% w/v fluoride ion)

Purpose

Anticavity toopaste

Use

helps protect against cavities

Warnings

Keep out of reach of children.

Keep out of reach of children under 6 years of age. Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

Directions

adults and children 2 years of age and and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
do not swallow.
to minimize swallowing use a pea-sized amount in children under 6.
supervise children's brushing until good habits are established.
children under 2 years: ask a dentist.

Inactive Ingredients

GLYCERIN, WATER, HYDRATED SILICA, SODIUM LAURYL SULFATE, FLAVOR, XANTHAN GUM, TETRASODIUM PYROPHOSPHATE, POLOXAMER 407, SODIUM POLYACRYLATE, ZINC STEARATE, SODIUM SACCHARIN, SORBITAN OLEATE, TITANIUM DIOXIDE, SUCRALOSE, HYDROXYAPATITE, NIACINAMIDE, TOCOPHERYL ACETATE, XYLITOL

Questions?

1-866-993-4709

Principal Display Panel - 160 g Tube Carton

POP

Playful. Original. Personal.

GEL TOOTHPASTE
Electric Toothbrush Suitable

3X faster fluoride release*
Repairs & protects enamel

NET WT. 5.64 OZ. (160 G)

Pumpin' Strawberry

DISTR. LG H&H CO., LTD.

58, SAEMUNAN-RO, JONGNO-GU,
SEOUL, KOREA
www.oralcarebypop.com

MADE IN KOREA

*Compared to tube toothpaste,
when used with an electric
toothbrush.

POP_Gel_Pumpkin_Strawberry_160g_IC

POP GEL PUMPIN STRAWBERRY
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53208-581
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
ZINC STEARATE (UNII: H92E6QA4FV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Strawberry)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53208-581-60	1 in 1 CARTON	09/18/2023
1		160 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	09/18/2023

Labeler - LG H&H CO., LTD. (688276187)

Name	Address	ID/FEI	Business Operations
Establishment
Tai Guk Pharma. Co., Ltd.		689060246	manufacture(53208-581)

POP Gel Pumpin' Strawberry Toothpaste 160g