SPL v2
SPL
SPL Set ID 769e9aae-39f2-4388-806c-18bd8b1101d7
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

Description

CETYLPYRIDINIUM CHLORIDE 0.05%

Purpose

Oral Antiseptic


Medication Information

Purpose

Oral Antiseptic

Description

CETYLPYRIDINIUM CHLORIDE 0.05%

Uses

■ Helps control bad breath

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

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

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

Active Ingredient

CETYLPYRIDINIUM CHLORIDE 0.05%

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

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

■ Helps control bad breath

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

Purpose (PURPOSE)

Oral Antiseptic

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

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

Active Ingredient (ACTIVE INGREDIENT)

CETYLPYRIDINIUM CHLORIDE 0.05%

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

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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