Home › NDC Lookup › Ingredients › Chlorhexidine Gluconate › 00126-0282-16
💊image loading
(from DailyMed)

Periogard Alcohol Free Chlorhexidine Gluconate 1.2 mg/mL Rinse, 473 mL

by Colgate Oral Pharmaceuticals, Inc. · 473 mL in 1 BOTTLE, PLASTIC (0126-0282-16)
NDC 00126-0282-16
🏷️ FDA NDC (as labeled) 0126-0282-16 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Chlorhexidine Gluconate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 18, 2026 — Cross Contamination with Other Products (Sage Products, LLC) · FDA recall D-0837-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0126-0282-16
Product NDC 0126-0282
11-digit billing NDC 00126028216
RxCUI 834127, 834137
UNII MOR84MUD8E
Application # ANDA203212
SPL Set ID 4993fc4a-bbe2-5ccb-de4d-44d73d484d39
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-04
Route BUCCAL
Dosage form RINSE
Substance CHLORHEXIDINE GLUCONATE
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 0126-0282-16 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00126-0282-16. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiinfectives and antiseptics for local oral treatment class.

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives, Biguanides and amidines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerColgate Oral Pharmaceuticals, Inc.
Application holderCOLGATE-PALMOLIVE CO
FDA applicationANDA203212 (ANDA)
Labeler code00126
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio16 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's actually a prescription-strength antimicrobial rinse, which is different from over-the-counter mouthwash. Your dentist prescribes it specifically to treat gingivitis — that's...
  • What exactly is chlorhexidine rinse for — is it just like a regular mouthwash?
  • Yes, tooth and surface staining is one of the most common side effects of chlorhexidine oral rinse. It can also increase tartar buildup on your teeth. The good news is that this is...
  • My teeth look like they're staining — is that from the rinse?
📖 Read our full Chlorhexidine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII D9OM4SK49P
    Cetylpyridinium chloride is a chemical compound that acts as a preservative and antimicrobial agent in medicines. It helps prevent bacterial growth and extends the shelf life of liquid formulations.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 4ERD2076EF
    A synthetic liquid made by combining polyethylene glycol with castor oil. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients, keeping the medicine uniform throughout the product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0200 $0.02 / 1 bottle
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 16571-0128-48 Rising 473 ml $0.007 AT Availability likely —
Chlorhexidine Gluconate 1.2 mg/mL 00116-2001-04 Xttrium 118 ml $0.017 AT Availability likely —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 [iU]/mL 00116-0003-15 Xttrium 15 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-0175-16 Xttrium 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-0301-15 Xttrium 15 ml — AT FDA listed —
NUPRO Chlorhexidine Gluconate 1.2 mg/mL 00116-0800-16 Xttrium 473 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00116-4075-01 Xttrium 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-6000-04 Xttrium 118 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00116-6720-04 Xttrium 118 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00121-0893-00 PAI 10 cups — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mL 00126-0272-16 Colgate 473 ml — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mLthis 00126-0282-16 Colgate 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00374-5080-01 Lyne 15 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00404-4075-01 Henry 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00904-7035-80 Major 1500 ml — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mL 17856-0272-01 ATLANTIC 72 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 17856-2001-03 Atlantic 10 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 17856-2002-03 ATLANTIC 15 ml — AT Discontinued —
Peridex 1.2 mg/mL 48878-0620-01 Solventum 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 50090-0722-00 A-S 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 53329-0301-24 Medline 15 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 53462-0003-15 Sage 15 ml — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 55154-1980-05 Cardinal 5 cups — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 55154-1981-05 Cardinal 5 cups — AT FDA listed —
Major Oral Rinse 1.2 mg/mL 55154-3573-05 Cardinal 5 cups — AT FDA listed —
Major Oral Rinse 1.2 mg/mL 55154-3574-05 Cardinal 5 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 59883-0175-16 Den-mat 473 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse 1.2 mg/mL 60687-0714-16 American 10 cups — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 61037-0469-02 Bajaj 118 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 62135-0649-41 Chartwell 120 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 62135-0650-24 Chartwell 10 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 63187-0685-16 Proficient 473 ml — AT FDA listed —
Sky Oral Rinse 1.2 mg/mL 63739-0052-57 McKesson 600 ml — AT FDA listed —
NUPRO Chlorhexidine Gluconate 1.2 mg/mL 65222-0800-16 Dentsply 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66467-2560-01 Darby 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66689-0106-50 VistaPharm, 50 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66975-0600-04 Benco 118 ml — AT FDA listed —
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 67239-0225-00 Safco 118 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 68071-1837-06 NuCare 473 ml — AT FDA listed —
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 68071-3630-06 NuCare 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 68788-9546-04 Preferred 473 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 68999-0650-24 Chartwell 10 cups — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 69339-0138-15 Natco 15 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 70518-4494-00 REMEDYREPACK 473 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 73141-0512-50 A2A 100 cups — AT FDA listed —
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 73614-0203-01 Brisk 118 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 81033-0512-50 Kesin 100 cups — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Chlorhexidine Gluconate (matched by generic name) — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Chlorhexidine Gluconate. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.96M
Claims incl. refills
658.9K
Beneficiaries
540.1K
Spend / beneficiary
$7.34
Spend / claim
$6.02
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00126-0282-16 You're viewing this 473 mL in 1 BOTTLE, PLASTIC (0126-0282-16) 2021-10-04 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0126-0282-16, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00126-0282-16, written without dashes as 00126028216. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00126-0282-16, the first segment (00126) is the labeler code FDA assigned to Colgate Oral Pharmaceuticals, Inc.; the middle segment (0282) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Colgate Oral Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Colgate Oral Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 65 words ▾

INDICATIONS AND USAGE PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. PerioGard® has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .

⏱️ Dosage and Administration 99 words ▾

DOSAGE AND ADMINISTRATION PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy should be initiated directly following a dental prophylaxis. Patients using PerioGard® should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing.

Usual dosage is 1/2 fl. oz. ("15 mL" line in dosage cap) of undiluted PerioGard®. Patients should be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using PerioGard®.

PerioGard® is not intended for ingestion and should be expectorated after rinsing.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS PerioGard® should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

⚠️ Warnings 86 words ▾

WARNINGS The effect of PerioGard® on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing with users of chlorhexidine gluconate oral rinse USP, 0.12% compared with control users. It is not known if chlorhexidine gluconate use results in an increase of subgingival calculus.

Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS .

🤒 Adverse Reactions 177 words ▾

ADVERSE REACTIONS The most common side effects associated with chlorhexidine gluconate oral rinse USP, 0.12% are: (1) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation, and (3) an alteration in taste perception; see WARNINGS and PRECAUTIONS . Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Each occurred at a frequency of less than 1.0%. Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse USP, 0.12% are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.

🤰 Pregnancy 70 words ▾

Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 19 words ▾

Pediatric Use Clinical effectiveness and safety of PerioGard® have not been established in children under the age of 18.

🆘 Overdosage 50 words ▾

OVERDOSAGE Ingestion of 1 or 2 ounces of PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) by a small child (~10 kg body weight) might result in gastric distress, including nausea. Medical attention should be sought if more than 4 ounces of PerioGard® Oral Rinse is ingested by a small child.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) provides antimicrobial activity during oral rinsing. The clinical significance of chlorhexidine gluconate oral rinse's antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months' use.

Use of chlorhexidine gluconate oral rinse USP, 0.12% in a six-month clinical study did not result in any significant changes in bacterial resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate oral rinse USP, 0.12% use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline. PHARMACOKINETICS Pharmacokinetic studies with a chlorhexidine gluconate oral rinse USP, 0.12% indicate approximately 30% of the active ingredient is retained in the oral cavity following rinsing.

This retained drug is slowly released into the oral fluids. Studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. The mean plasma level of chlorhexidine gluconate reached a peak of 0.206 µg/g in humans 30 minutes after they ingested a 300-mg dose of the drug.

Detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered. Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

📦 How Supplied / Storage and Handling 54 words ▾

HOW SUPPLIED PerioGard® is supplied as a blue liquid in a 16-fluid ounce (473 mL) (NDC 0126-0282-16) amber plastic bottle with child-resistant dosage cap. Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx Only. Keep out of reach of children.

📦 Storage and Handling 30 words ▾

Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx Only. Keep out of reach of children.

📋 Description 69 words ▾

DESCRIPTION PerioGard® (Chlorhexidine Gluconate Oral rinse USP, 0.12%) is an oral rinse containing 0.12% chlorhexidine gluconate (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, propylene glycol, glycerin, sorbitol, polyoxyl 40 hydrogenated castor oil, flavor, cetylpyridinium chloride, and FD&C blue no. 1. PerioGard® product is a near neutral solution (pH range 5-7).

Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is: Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00126-0272-16 · Colgate 00126-0286-66 · Colgate →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.