Basics 299.005/299ak-al

SPL v23

SPL

SPL Set ID 91626efe-520d-457f-8d72-7a95a8877301

Route

ORAL

Published

Effective Date 2025-09-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetylpyridinium (0.7 mg)

Inactive Ingredients

Water Glycerin Poloxamer 188 Saccharin Sodium Propylene Glycol Sodium Benzoate Sucralose Benzoic Acid Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-04-25

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

DISTRIBUTED BY: Amazon.com Services LLC Seattle, WA 98109 1-877-485-0385 ©2025 Amazon Basics Services LLC or its Affiliates. All rights reserved. www.amazon.com/amazonbasics Made in USA with U.S. and foreign components. Discard Seal, Empty & Replace Cap PLASTIC BOTTLE how2recycle.info

Medication Information

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

DISTRIBUTED BY:

Amazon.com Services LLC

Seattle, WA 98109 1-877-485-0385

www.amazon.com/amazonbasics

Made in USA with U.S. and foreign components.

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

Use

helps control plaque that leads to gingivitis

Claims

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurence.

Warnings

for this product

Directions

adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
do not swallow
children 6 years to under 12 years of age: supervise use
when used after brushng, rinse mouth with water first
children under 6 years of age: do not use

Other Information

this rinse is not intended to replace brushing or flossing

Active Ingredient

Cetylpyridinium Chloride 0.07%

Inactive Ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Principal Display Panel

amazon basics

Fresh Mint

Multi Action

Antiseptic

Oral Rinse

Antigingivitis / Antiplaque

Alcohol Free

Fresh Mint

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

Stop Use and Ask A Dentist If

gingivitis, bleeding or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control center right away.

Structured Label Content

Use

helps control plaque that leads to gingivitis

Claims

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurence.

Purpose

Antigingivitis, Antiplaque

Warnings

for this product

Directions

adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
do not swallow
children 6 years to under 12 years of age: supervise use
when used after brushng, rinse mouth with water first
children under 6 years of age: do not use

Adverse Reactions (Adverse reactions)

DISTRIBUTED BY:

Amazon.com Services LLC

Seattle, WA 98109 1-877-485-0385

www.amazon.com/amazonbasics

Made in USA with U.S. and foreign components.

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Other Information (Other information)

this rinse is not intended to replace brushing or flossing

Active Ingredient (active ingredient)

Cetylpyridinium Chloride 0.07%

Inactive Ingredients (inactive ingredients)

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Principal Display Panel (principal display panel)

amazon basics

Fresh Mint

Multi Action

Antiseptic

Oral Rinse

Antigingivitis / Antiplaque

Alcohol Free

Fresh Mint

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

gingivitis, bleeding or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control center right away.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 188", "unii": "LQA7B6G8JG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM", "unii": "CUB7JI0JV3", "classCode": "ACTIB", "strengthNumerator": "0.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "helps control plaque that leads to gingivitis", "Claims": "This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.", "Purpose": "Antigingivitis, Antiplaque", "Warnings": "for this product", "Directions": "adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use when used after brushng, rinse mouth with water first children under 6 years of age: do not use", "Adverse reactions": "DISTRIBUTED BY: Amazon.com Services LLC Seattle, WA 98109 1-877-485-0385 ©2025 Amazon Basics Services LLC or its Affiliates. All rights reserved. www.amazon.com/amazonbasics Made in USA with U.S. and foreign components. Discard Seal, Empty & Replace Cap PLASTIC BOTTLE how2recycle.info", "Other information": "this rinse is not intended to replace brushing or flossing", "active ingredient": "Cetylpyridinium Chloride 0.07%", "inactive ingredients": "water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1", "principal display panel": "amazon basics Fresh Mint Multi Action Antiseptic Oral Rinse Antigingivitis / Antiplaque Alcohol Free Fresh Mint 33.8 FL OZ (1.05 QT) 1 L", "Tamper Evident Statement": "SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.", "Stop use and ask a dentist if": "gingivitis, bleeding or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.", "Keep out of reach of children under 6 years of age.": "If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:01.293921 · Updated: 2026-03-14T23:14:04.878170