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RevitaDERM Wound Care BENZALKONIUM CHLORIDE 170 mg/89mL Gel, 89 mL — NDC 63347-0120-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

RevitaDERM Wound Care BENZALKONIUM CHLORIDE 170 mg/89mL Gel, 89 mL — NDC 63347-120-01 (Billing 63347-0120-01)

by Blaine Labs Inc. · 89 mL in 1 TUBE

This is a package of 89 mL of RevitaDERM Wound Care BENZALKONIUM CHLORIDE 170 mg/89mL Gel from Blaine Labs Inc., marketed since May 2012 and currently FDA-listed. It is this product's only package size.

NDC 63347-0120-01
🏷️ FDA NDC (as labeled) 63347-120-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 63347-120-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63347 labeler · 120 product · 01 package
Package marketed since
May 24, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
89 mL per package
Barcode (UPC-A, from the NDC)
3 6334712001 6
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Lots / codes: Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27 · reported Jul 8, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Benzalkonium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0366-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0376-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0361-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0359-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0371-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class I · Jan 25, 2022 · Terminated — Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus. (Blaine Labs Inc) · FDA recall D-0668-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63347-120-01
Product NDC 63347-120
11-digit billing NDC 63347012001
NCPDP billing unit ML — per mL (volume)
RxCUI 1049228, 1310820
UNII F5UM2KM3W7
Application # M003
SPL Set ID 9254dada-4e32-43a0-892b-c488d68e23e7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-05-24
Route TOPICAL
Dosage form GEL
Substance BENZALKONIUM CHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90944000004000
GPI class RevitaDERM Wound Care
GCN Seq No 070960
GCN 34633
HICL code 004258
Ingredient (HICL) Benzalkonium Chloride
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5B
Therapeutic class — specific (HIC3) Topical Preparations,Antibacterials
AHFS code 84:04.16.00
AHFS class Astringents, Anti-Infective
FDB label name REVITADERM WOUND CARE 0.1% GEL
FDB brand name Revitaderm
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 070960
  • GCN: 34633
  • GPI-14 (Medi-Span): 90944000004000
  • HICL (First Databank): 004258
  • AHFS class code: 84:04.16.00
  • RxCUI (RxNorm): 1049228
Why two NDCs? The FDA registers this code as 63347-120-01 — a 5-3-2 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 product segment → 63347-0120-01. 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 Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
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.

Clinical

Label name REVITADERM WOUND CARE 0.1% GEL Ingredient Benzalkonium Chloride
🧪 What is this product?

RevitaDERM Wound Care is an over-the-counter topical gel containing benzalkonium chloride, a chemical commonly used as an antimicrobial agent in wound care products. When applied to the skin, benzalkonium chloride functions as an antiseptic to help reduce bacteria and microorganisms on minor wounds and affected areas. This product is marketed under the FDA's over-the-counter monograph rules for its drug category rather than through individual product approval.

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.

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 gPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63347-0120-01 You're viewing this Main listing 89 mL in 1 TUBE 2012-05-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
RevitaDERM Wound Care 170 mg/89mLthis 63347-0120-01 Blaine 89 ml — — FDA listed —
Tridergel .001 g/mL 73352-0520-01 Trifluent 29.6 ml — — FDA listed —
Ops Instant Hand Sanitizer .1 g/100mL 79016-0105-12 Archer 1000 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2012
On the market since
May 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • 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 S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII ZR28QKN0WT
    Hydrolyzed elastin is a protein derived from animal connective tissue that has been broken down into smaller components. It acts as a humectant and skin-conditioning agent in formulations, helping to retain moisture and improve texture.
  • UNII 0QQJ25X58G
    Isobutylparaben is a preservative derived from para-hydroxybenzoic acid. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.

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

The official label also statesInactive ingredients Aloe Barbadensis (Aloe) Leaf Juice, Aloe Barbadensis (Aloe) oil extract, Carbomer, Collagen, Elastin, Glycerin, Hyaluronic Acid, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

Manufacturer & labeler

LabelerBlaine Labs Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code63347
First marketedMay 2012
Product typeHuman Otc Drug
Portfolio14 products on file

More NDCs from Blaine Labs Inc. labeler code 63347

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

Uses Uses * 1st and 2nd Degree Burns * Stasis Ulcers * Pressure Ulcers * Diabetic Ulcers * Lacerations * Abrasions * Skin Tears * Surgical Incision Sites * Device Insertion Sites * Graft Sites * Donor Sites

⏱️ Dosage and Administration 31 words ▾

Directions Directions Evenly apply RevitaDERM Wound Care approximately 1/8 inch to 1/4 inch thick to the wound area. Cover wound with appropriate dressing. Repeat as necessary to keep the wound moist.

⚠️ Warnings 6 words ▾

Warnings Warnings For external use only.

🧪 Active Ingredient 7 words ▾

Active Ingredients Active Ingredients Benzalkonium Chloride (0.1%)

🧪 Inactive Ingredients 27 words ▾

Inactive Ingredients Inactive ingredients Aloe Barbadensis (Aloe) Leaf Juice, Aloe Barbadensis (Aloe) oil extract, Carbomer, Collagen, Elastin, Glycerin, Hyaluronic Acid, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

🎯 Purpose 3 words ▾

Purpose Purpose Antimicrobial

📄 Ask a Doctor Before Use If 139 words ▾

Ask a doctor before use Ask a doctor before use RevitaDERM Wound Care Gel is for external use only. Avoid contact with eyes. If you get it in your eyes, rinse immediately with cool tap water.

RevitaDERM Wound Care Gel may become discolored when it mixes with fluid from the wound. This is normal and not a cause for concern. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.

Talk with your doctor before you use any other medicines or cleansers on your skin. RevitaDERM Wound Care Gel does not contain sunscreen. Ask you doctor before you use RevitaDERM Wound Care Gel if you must be outside for a long period of time.

If your symptoms do not get better or if they get worse, check with your doctor.

📄 Keep Out of Reach of Children 25 words ▾

Keep Out Of Reach Of Children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 34 words ▾

Product Label Blaine Labs RevitaDERM WOUND CARE GEL 3 fl. oz. PHYSICIAN FORMULA NDC: 63347-120-01 (800) 307-8818 [email protected] www.BlaineLabs.com Blaine Labs, Inc. Santa Fe Springs, CA 90670 Rev. 20120820 res Blaine RevitaDERM1 Blaine RevitaDERM2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) 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 ✓ Available
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Blaine Labs Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Blaine Labs 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 63347-0112-01 · Blaine 63347-0130-01 · Blaine →
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.