FLUORIDE GEL- sodium fluoride paste

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Sodium Fluoride 0.22%(0.15 w/v Fluoride ion), anticavity
Available from:
Yangzhou Hongshengding Chemical Co.,Ltd.
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
helps protect against cavities.
Authorization status:
OTC monograph not final
Authorization number:
71035-400-01, 71035-400-02, 71035-400-03, 71035-400-04, 71035-400-05

FLUORIDE GEL- sodium fluoride paste

Yangzhou Hongshengding Chemical Co.,Ltd.

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.

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Charm-Tex Fluoride Gel Toothpaste

Active ingredients

Sodium Fluoride 0.22%(0.15 w/v Fluoride ion)

Purpos e

anticavity

Us es

helps protect against cavities.

Warnings

Keep out of the 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 immediately.

Keep out of reach of children.

Directions

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at

least twice a day,or as directed by a dentist or a physician.

Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize

swallowing)

Children under 2 years:Ask a dentist or a physician.

INACTIVE INGREDIENT

Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated

Water,SCMC,Sodium Lauryl Sulfate

FLUORIDE GEL

sodium fluoride paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:710 35-40 0

Route of Administration

DENTAL

Yangzhou Hongshengding Chemical Co.,Ltd.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

0 .22 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO CYSTEINE LYSINE MO NO HYDRATE (UNII: QA5ZP9 OL3E)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

METHYL PARAO XO N (UNII: UE1A2XL9 5H)

PRO PYLPARABEN SO DIUM (UNII: 6 25NNB0 G9 N)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM SILICATE (UNII: IJF18 F77L3)

PO TASSIUM SO DIUM SACCHARATE (UNII: 73U34YC9 0 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:710 35-40 0 -0 1

720 in 1 BOX

0 5/25/20 16

1

17 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:710 35-40 0 -0 2

720 in 1 BOX

0 5/25/20 16

2

24 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:710 35-40 0 -0 3

144 in 1 BOX

0 3/0 7/20 16

3

43 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:710 35-40 0 -0 4

10 0 0 in 1 BOX

0 5/0 1/20 15

4

0 .22 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

5

NDC:710 35-40 0 -0 5

10 0 0 in 1 BOX

0 5/0 1/20 15

5

7 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 5/0 1/20 15

Labeler -

Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Registrant -

Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Yangzho u Ho ngshengding Chemical Co .,Ltd.

543774755

ma nufa c ture (710 35-40 0 )

Revised: 1/2018

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