DENTALUX KIDS ANTICAVITY FLUORIDE TOOTH BUBBLE GUM- sodium fluoride paste

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

Buy It Now

Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
LIDL US, LLC
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
ANTICAVITY HELPS PROTECT AGAINST CAVITIES
Authorization status:
OTC monograph final
Authorization number:
71141-162-32

DENTALUX KIDS ANTICAVITY FLUORIDE TOOTH BUBBLE GUM- sodium fluoride paste

LIDL US, LLC

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.

----------

DENTALUX KID'S ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR

ACTIVE INGREDIENT

SODIUM FLUORIDE 0.243%

(0.14% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY

USE

HELPS PROTECT AGAINST CAVITIES

WARNINGS

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally

swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

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

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

Do not swallow

To minimize swallowing use a pea sized amount in children under 6

Supervise children until good brushing and rinsing habits are established.

For children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENTS

water, sorbitol, hydrated silica, propylene glycol, sodium C14-16 olefin sulfonate, xanthan gum, flavor,

sodium saccharin, tocopheryl acetate, sodium methylparaben, mica, titanium dioxide, iron oxides, FD&C

blue no. 1

QUESTIONS?

1-844-656-5151

www.lidl.com

DENTALUX KIDS ANTICAVITY FLUORIDE TOOTH BUBBLE GUM

LIDL US, LLC

sodium fluoride paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71141-16 2

Route of Administration

DENTAL

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 .243 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U)

XANTHAN GUM (UNII: TTV12P4NEE)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

METHYLPARABEN SO DIUM (UNII: CR6 K9 C2NHK)

MICA (UNII: V8 A1AW0 8 8 0 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71141-16 2-32

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

0 4/24/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 4/24/20 19

Labeler -

LIDL US, LLC (079389709)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

DENTAL-Ko smetik GmbH & Co . KG

330 6 26 30 0

ma nufa c ture (71141-16 2)

Revised: 4/2019

Similar products

Search alerts related to this product

View documents history

Share this information