PERIOE Whitening Essentials Fresh Aloe Green Mint: Package Insert and Label Information

PERIOE WHITENING ESSENTIALS FRESH ALOE GREEN 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.

Drug Facts

Drug Facts

Active Ingredient

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

Purpose

Anticavity

Use

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.

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, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica, charcoal powder, citru limon(lemon) fruit extract, sodium chloride, aloe extract

1-800-FOR-AVON

www.avon.com

Principal Display Panel — 156 g Tube Carton

PERIOE

Whitening Essentials. ALOE

FLUORIDE TOOTHPASTE

CAVITY PROTECTION

HELPS WHITEN TEETH — REMOVES SURFACE STAINS

FRESH ALOE

GREEN MINT

NET WT 5.5 oz (156 g)

PERIOE Whitening Essentials Fresh Aloe Green Mint 156gPERIOE Whitening Essentials Fresh Aloe Green Mint 156g
PERIOE WHITENING ESSENTIALS FRESH ALOE GREEN MINT
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-802
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.6 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
HEXASODIUM HEXAMETAPHOSPHATE
CARRAGEENAN
GLYCERIN
WATER
POLYETHYLENE GLYCOL 300
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
SODIUM LAURYL SULFATE
COCAMIDOPROPYL BETAINE
SACCHARIN SODIUM (SACCHARIN)
SUCRALOSE
TITANIUM DIOXIDE
CITRUS LIMON FRUIT OIL
SODIUM CHLORIDE
HYDRATED SILICA
XANTHAN GUM
MICA
ACTIVATED CHARCOAL
SILICON DIOXIDE
ALOE
Product Characteristics
Color green Score
Shape Size
Flavor MINT (Fresh Aloe) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43136-802-01 1 TUBE in 1 CARTON contains a TUBE
1 156 g in 1 TUBE This package is contained within the CARTON (43136-802-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 03/31/2020
Labeler — Tai Guk Pharm. Co., Ltd. (689060246)
Establishment
Name Address ID/FEI Operations
Tai Guk Pharma. Co., Ltd. 689060246 manufacture (43136-802)

Revised: 03/2020 Tai Guk Pharm. Co., Ltd.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.