G.U.M- sodium fluoride,cetylpyridinium chloride paste

G.U.M by

Drug Labeling and Warnings

G.U.M by is a Otc medication manufactured, distributed, or labeled by Sunstar Guangzhou Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

SODIUM FLUORIDE 0.21%

CETYLPYRIDINIUM CHLORIDE 0.5%

Purpose

Anticavitytoothpaste

Use

aids in the prevention of dental decay

Warning

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

Directions

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

do not swallow

to minimize swallowing use a pea-sized amount in children under 6

supervise children's burshing ntil good habits are established

children under 2 years ask a dentist

Inactive Ingredients

WATER,SORBITOL,XANTHAN GUM,SODIUM SILICATE,TRIPOTASSIUM GLYCYRRHIZINATE,PROPYLENE GLYCOL DIACETATE,SODIUM LAURYL SULFATE,CELLULOSE ACETATE,TITANIUM DIOXIDE,CETYLPYRIDINIUM CHLORIDE,SACCHARIN SODIUM,CETYL HYDROXYETHYLCELLULOSE (350000 MW),GLYCERIN

Keep out of reach of children under 6 years of age

Keep out of reach of children under 6 years of age

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

G.U.M 
sodium fluoride,cetylpyridinium chloride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53050-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.21 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM SILICATE (UNII: IJF18F77L3)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIPOTASSIUM GLYCYRRHIZINATE (UNII: LD4YKZ48B6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53050-002-01	3 g in 1 TUBE; Type 0: Not a Combination Product	03/23/2017	01/15/2021
2	NDC: 53050-002-02	6 g in 1 TUBE; Type 0: Not a Combination Product	03/23/2017	02/28/2020
3	NDC: 53050-002-03	9 g in 1 TUBE; Type 0: Not a Combination Product	03/23/2017	02/28/2020
4	NDC: 53050-002-04	14 g in 1 TUBE; Type 0: Not a Combination Product	03/23/2017	02/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/10/2016	01/15/2021

Labeler - Sunstar Guangzhou Ltd. (544725724)

Establishment
Name	Address	ID/FEI	Business Operations
Sunstar Guangzhou Ltd.		544725724	manufacture(53050-002)