d37ae939-a0e3-47b7-8cd8-bce91b9a28b7

SPL v2
SPL
SPL Set ID d37ae939-a0e3-47b7-8cd8-bce91b9a28b7
Route
topical
Published
Effective Date 2021-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.0085 g)
Inactive Ingredients
water alcohol glycerin

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2021-02-01

Purpose

Oral Antiseptic

Description

CETYLPYRIDINIUM CHLORIDE 0.05%


Medication Information

Warnings

■ Do not use if you are allergic to any of the ingredients



Stop use and ask a dentist if ■Swelling, rash or fever develops. ■ Irritation, pain or redness persists or worsens.



Keep out of the reach of children

Uses

■ Helps control bad breath

■ aids in the removal or debris, dental plaque and control bacteria.

Purpose

Oral Antiseptic

Directions

■ Spray directly into mouth, onto the tongue and spread thoroughly inside the mouth.

■ Children 12 years and under Not for us unless directed by a healthcare professional

Inactive Ingredients

Water, Ethanol, Glycerin , Flavor , Xylitol , L-Menthol, Polysorbate 80 , PEG-40 Hydrogenated Castor Oil , Poloxamer 407 , Saccharin Sodium Dihydrate , Enzymatically Modified Stevia Glucosyl Stevia , Cetyl Pyridinium Chloride , Eucalyptus oil , Citric acid, Sodium Citrate, Peony root Extract, Syzygium aromaticum extract , Betula Platyphylla Japonica Bark Extract , Peppermint oil , Green tea Extract , Scutellaria Baicalensis Extract , Nasturtium Officinale Extract , Rubus Idaeus (Raspberry) Fruit Extract , Petroselinum Sativum (Parsley) Extract, Gardenia Jasminoides Fruit Extract

Description

CETYLPYRIDINIUM CHLORIDE 0.05%

Active Ingredient

CETYLPYRIDINIUM CHLORIDE 0.05%

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Warnings (WARNINGS)

■ Do not use if you are allergic to any of the ingredients



Stop use and ask a dentist if ■Swelling, rash or fever develops. ■ Irritation, pain or redness persists or worsens.



Keep out of the reach of children

Uses

■ Helps control bad breath

■ aids in the removal or debris, dental plaque and control bacteria.

Purpose (PURPOSE)

Oral Antiseptic

Directions

■ Spray directly into mouth, onto the tongue and spread thoroughly inside the mouth.

■ Children 12 years and under Not for us unless directed by a healthcare professional

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Ethanol, Glycerin , Flavor , Xylitol , L-Menthol, Polysorbate 80 , PEG-40 Hydrogenated Castor Oil , Poloxamer 407 , Saccharin Sodium Dihydrate , Enzymatically Modified Stevia Glucosyl Stevia , Cetyl Pyridinium Chloride , Eucalyptus oil , Citric acid, Sodium Citrate, Peony root Extract, Syzygium aromaticum extract , Betula Platyphylla Japonica Bark Extract , Peppermint oil , Green tea Extract , Scutellaria Baicalensis Extract , Nasturtium Officinale Extract , Rubus Idaeus (Raspberry) Fruit Extract , Petroselinum Sativum (Parsley) Extract, Gardenia Jasminoides Fruit Extract

Active Ingredient (ACTIVE INGREDIENT)

CETYLPYRIDINIUM CHLORIDE 0.05%

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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