FDA.reportPublic FDA data

Primocyn Eau Divine Eyelid & Eyelash Cleanser

Primary DI
00189116000262
Brand
Primocyn Eau Divine Eyelid & Eyelash Cleanser
Company
Sonoma Pharmaceuticals, Inc.
Model
85049
Catalog number
85049
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20189116000266PackageGS112In Commercial Distribution
00189116000262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2018911600026620189116000266
00189116000262001891160002621891160002620189116000262

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid solutionA fluid material intended to be applied to the eyelids for various therapeutic ocular applications that typically include provision of supplemental lipids on the eyelid margin to stabilize the natural tear film lipid layer in the treatment of tear film deficiencies (e.g., dry eye syndrome), or to clean the eyelid or eyelid margin in the treatment of blepharitis and/or meibomian gland dysfunction. It is typically a liposomal (e.g., phospholipid) suspension or a saline solution, and is intended for use in the home or healthcare facility (single dose or multidose). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume89Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081642964
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10365197851000Bactine Antimicrobial Hydrogel Spray 86045851002026-01-16
00365197409204A+D Hydrogel Spray Advanced Dermatitis Care86046409202025-11-24
00365197409402A+D Gentle Face Relief86049409402025-11-24
20365197409208A+D Hydrogel Spray Advanced Dermatitis Care86046409202025-11-24
20365197409406A+D Gentle Face Relief86049409402025-11-24
00850015491849Aquanil Repair Mist86050860502025-11-04
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00850015491863Aquanil Rescue Serum86052860522025-11-04
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00850015491900Myze The Spray86057860572025-11-04
00365197760008Intimate Skin Cleansing Spray86048760002025-10-08
00365197760107Bikini Skin Soothing Gel86047760102025-10-08
00365197504107Solarcaine Advanced Burn Relief Hydrogel50410504102025-09-05
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00365197504008Solarcaine Advanced Burn Relief Hydrogel86035860352025-07-22
00365197851102Bactine Antimicrobial Wound Care Hydrogel86043860432025-07-22
20365197504002Solarcaine Advanced Burn Relief Hydrogel86035860352025-07-22
20365197851106Bactine Antimicrobial Wound Care Hydrogel86043860432025-07-22

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Primary DI, Brand, Company table
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00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
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00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
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00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
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