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NDC 53462-0175-60 Antiseptic Oral Rinse 0.5 mg/mL Details

Antiseptic Oral Rinse 0.5 mg/mL

Antiseptic Oral Rinse is a BUCCAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by Sage Products LLC. The primary component is CETYLPYRIDINIUM CHLORIDE.

Product Information

NDC	53462-0175
Product ID	53462-175_d8a01fea-681a-2a16-e053-2a95a90ad13f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Antiseptic Oral Rinse
Proprietary Name Suffix	n/a
Non-Proprietary Name	CETYLPYRIDINIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	BUCCAL
Active Ingredient Strength	0.5
Active Ingredient Units	mg/mL
Substance Name	CETYLPYRIDINIUM CHLORIDE
Labeler Name	Sage Products LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 53462-0175-60 (53462017560)

Pricing Information	N/A
NDC Package Code	53462-175-60
Billing NDC	53462017560
Package	7 mL in 1 PACKET (53462-175-60)
Marketing Start Date	2001-12-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL efff8bae-154d-46bc-8dd4-716800425663 Details

Active ingredient

Cetylpyridinium chloride .05%

Purpose

Antiseptic Rinse

Use

Helps reduce chance of infection in minor oral irritation.

Warnings

Stop use and ask a doctor if:

Sore mouth symptoms do not improve in 7 days.
Swelling, rash or fever develops.
Irritation, pain or redness persists or worsens.

Keep out of reach of children. If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use up to 4 times daily or as directed by a dentist or doctor.
Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette ® Oral Swab. Instruct to expectorate.
Children under 12 years of age: supervise use.
Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090)

Questions?

Call toll free 800-323-2220

Antiseptic Oral Rinse

INGREDIENTS AND APPEARANCE

ANTISEPTIC ORAL RINSE

cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53462-175
Route of Administration	BUCCAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PEPPERMINT (UNII: V95R5KMY2B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53462-175-60	7 mL in 1 PACKET; Type 0: Not a Combination Product	12/28/2001

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	06/21/2000

Labeler - Sage Products LLC (054326178)

Revised: 2/2022

Document Id: d8a01fea-681a-2a16-e053-2a95a90ad13f

Set id: efff8bae-154d-46bc-8dd4-716800425663

Version: 8

Effective Time: 20220222