POP GEL PUMPIN STRAWBERRY- sodium fluoride paste, dentifrice

POP Gel Pumpin Strawberry by

Drug Labeling and Warnings

POP Gel Pumpin Strawberry by is a Otc medication manufactured, distributed, or labeled by Tai Guk Pharm. Co., Ltd., LG H&H CO., LTD., Tai Guk Pharma. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredient

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

Purpose

Anticavity toopaste

Use

helps protect against cavities

Warnings

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.

INGREDIENTS AND APPEARANCE

POP GEL PUMPIN STRAWBERRY 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43136-521
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43136-521-60	1 in 1 CARTON	09/18/2023
1		160 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/18/2023

Labeler - Tai Guk Pharm. Co., Ltd. (689060246)

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

Establishment
Name	Address	ID/FEI	Business Operations
Tai Guk Pharma. Co., Ltd.		689060246	manufacture(43136-521)