AVON WHITENING ESSENTIALS ORIGINAL COOL MINT- sodium fluoride paste, dentifrice

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

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Tai Guk Pharm. Co., Ltd.
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity helps protect against cavities
Authorization status:
OTC monograph final
Authorization number:
43136-901-01

AVON WHITENING ESSENTIALS ORIGINAL COOL MINT- sodium fluoride paste,

dentifrice

Tai Guk Pharm. 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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AVON Whitening Essentials Original Cool Mint

Drug Facts

Drug Facts

Active Ingredient

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpos e

Anticavity

Us e

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 more than used for brushing is

accidentally swallowed, get medical help or contact a Poison Control Center right away. If an allergic

reaction develops, discontinue to use immediately.

Directions

Adults and children 6

years and older

Brush teeth thoroughly after each means or at least twice a day, or as directed

by a dentist and physician. Do not swallow.

Children between 6

and 12 years

To minimize swallowing, use a pea-sized amount and supervise children's

brushing and rinsing until good habits are established.

Children under 6 years Ask a dentist or physician.

Inactive Ingredients

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, flavor, trisodium

phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose,

xanthan gum, titanium dioxide, mica, charcoal powder, citrus limon(lemon) fruit extract, sodium chloride

1-800-FOR-AVON

www.avon.com

Principal Display Panel - 156 g Tube Carton

AVON

Whitening Essentials

FLUORIDE TOOTHPASTE

CAVITY PROTECTION

HELPS WHITEN TEETH - REMOVES SURFACE STAINS

ORIGINAL

COOL MINT

NET WT 5.5 oz (156 g)

AVON WHITENING ESSENTIALS ORIGINAL COOL MINT

sodium fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43136 -9 0 1

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

1.6 mg in 1 g

Tai Guk Pharm. Co., Ltd.

Inactive Ingredients

Ingredient Name

Stre ng th

HEXASO DIUM HEXAMETAPHO SPHATE (UNII: N40 N9 1DW9 6 )

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

PO LYETHYLENE GLYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)

SO DIUM PHO SPHATE, TRIBASIC, ANHYDRO US (UNII: SX0 1TZO3QZ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

XANTHAN GUM (UNII: TTV12P4NEE)

MICA (UNII: V8 A1AW0 8 8 0 )

CITRUS LIMO N FRUIT O IL (UNII: 0 HNC1J1YED)

ACTIVATED CHARCO AL (UNII: 2P3VWU3H10 )

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

MINT (Co o l)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:43136 -9 0 1-0 1

1 in 1 CARTON

0 7/31/20 19

1

156 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 final

pa rt355

0 7/31/20 19

Labeler -

T ai Guk Pharm. Co., Ltd. (689060246)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Tai Guk Pharma. Co ., Ltd.

6 8 9 0 6 0 246

ma nufa c ture (43136 -9 0 1)

Revised: 7/2019

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