FDA.reportPublic FDA data

MuGard

Primary DI
00860013569907
Brand
MuGard
Company
Soleva Pharma LLC
Model
Mucoadhesive Oral Wound Rinse
Device description
MuGard Mucoadhesive Oral Wound Rinse (MuGard) is a non-sterile slightly viscous liquid consisting of film-forming polymers, humectant and dispersion aids, preservatives, sweeteners/flavors and pH modifiers, namely: carbomer homopolymer A, polysorbate 60, glycerin, benzyl alcohol, citric acid, sodium saccharin, potassium hydroxide, and phosphoric acid. The rinse solution is supplied in a flat, white, opaque, eight fluid ounce, high-density polyethylene (HDPE) bottle.
Published
2025-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
OLROral Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU
OLROral Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062795000MUGARD MUCOADHESIVE ORAL WOUND RINSEAccess Pharmaceuticals, Inc.2006-12-11OLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013569907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013569907008600135699078600135699070860013569907

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-319-7272medinfo@solevapharma.com

Regulatory Flags#

DUNS number
063304531
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
04714691213958VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2026-03-30
04714691213934VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-11-04
00850058790114RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790121RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790138G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790145G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790152G4Derm PlusGel4med, Inc.MGQ2025-10-17
04714691213903HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213910HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213897HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-22
04714691213859HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-06-12
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
04714691213705Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213712Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
04714691213682Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213699Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
04714691213552HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213569HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213576HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850443Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850450Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213521HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213538HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213545HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213606Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213590Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18