FDA.reportPublic FDA data

2.5 oz Silky Moisture Personal Lubricant

Primary DI
00050428523940
Brand
2.5 oz Silky Moisture Personal Lubricant
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
796382
Device description
CVS/pharmacy® Silky Moisture is a water-based, non-sticky formula with Vitamin E and soothing Aloe. It is formulated to provide long lasting moisture for greater comfort and pleasure. Designed to feel like your own natural moisture, it gives immediate relief from temporary personal dryness. Use CVS/pharmacy® Silky Moisture to enhance your most intimate moments.
Published
2016-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013086000WET LIGHT PERSONAL MOISTURIZERTrigg Laboratories, Inc.2001-12-13HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00050428523940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428523940000504285239400504285239400050428523940

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
702.957.4400Samt@trigglabs.com

Regulatory Flags#

DUNS number
062312574
Device count
1
Lot or batch
true
Expiration date on label
true

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00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
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