Label: POP GEL WHATZZUP WATERMELON- sodium fluoride paste, dentifrice
- NDC Code(s): 43136-522-60
- Packager: Tai Guk Pharm. Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 18, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warnings
-
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
- Questions?
-
Principal Display Panel - 160 g Tube Carton
POP
Playful. Original. Personal.
GEL TOOTHPASTE
Electric Toothbrush Suitable3X faster fluoride release*
Repairs & protects enamelNET WT. 5.64 OZ (160 G)
Whatzzup Watermelon
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 WHATZZUP WATERMELON
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-522 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 (Watermelon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-522-60 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(43136-522)