FDA.reportPublic FDA data

Promescent

Manufacturer
Absorption | Inspec Solutions, LLC | Inspec Solutions LLC
Effective date
2026-06-30
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
weekly-update
Hydrated at
2026-07-17 21:41:43

Label at a glance#

ProductPromescent
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Break front tab first. To unlock, press in special Child Resistant (R) tab in back of the actuator while turning the actuator to the right. Press the actuator down repeatedly until product dispenses to prime spray pump. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 10 minutes before sexual intercourse, or use as directed by a doctor. Recommended Initial Dosage: 3 sprays. Rub Promescent into ...

Label contents#

Full prescribing information#

Active Ingredient (per spray)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine approx. 10mg

Purpose

OTC - PURPOSE SECTION

Anesthetic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Use:

INDICATIONS & USAGE SECTION

Helps in temporarily slowing the onset of ejaculation.

Warnings:

WARNINGS SECTION

​For external use only.​

​Do not use if​

  • You or your partner are allergic to lidocaine or topical anesthetics.
  • Your partner is, or may be pregnant.

​Ask a doctor or pharmacist before use if​

  • You have liver problems.

​When using this product​

  • Do not spray on broken, irritated or sensitive skin.
  • Avoid contact with the eyes.

​Stop use and ask a doctor

  • If you or your partner develop a rash or irritation, such as burning or itching, dicontinue use. If symptoms persist, consult a doctor.
  • Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed does not provide relief, discontinue use and consult a doctor. ​​

Directions:

DOSAGE & ADMINISTRATION SECTION

Break front tab first. To unlock, press in special Child Resistant (R) tab in back of the actuator while turning the actuator to the right. Press the actuator down repeatedly until product dispenses to prime spray pump. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 10 minutes before sexual intercourse, or use as directed by a doctor. Recommended Initial Dosage: 3 sprays. Rub Promescent into the skin of the penis until all of the product is absorbed. Wash product off after intersourse. After spraying, turn actuator to the left to lock.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Dimethicone, Farnesol, Fragrance, Glycerin, Hydrogenated Polyisobutene, Macadamia Ternifolia Seed Oil, Panthenol, Phenoxyethanol, Purified Water (Aqua), SD Alcohol 40-B, Sodium Hydroxide, Soy Lecithin, Stearoxytrimethylsilane, Stearyl Alcohol, Thymol, Tocopheryl Acetate (Vitamin E).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codel.ead.me/bauuM6Screenshot 2026-06-30 082352.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55636-590-132020-03-10C16284748780-19855d018-d2e6-cd31-e053-dbdaa90ab51aPromescent
55636-590-132020-03-10C16284748780-19855d018-d2e6-cd31-e053-dbdaa90ab51aPromescent
55636-590-742020-03-10C16284748780-19855d018-d2e6-cd31-e053-dbdaa90ab51aPromescent
55636-590-742020-03-10C16284748780-19855d018-d2e6-cd31-e053-dbdaa90ab51aPromescent
55636-590-132019-11-27C16284748780-19855d018-d2e6-cd31-e053-dbdaa90ab51aPromescent
55636-590-132019-11-27C16284748780-19855d018-d2e6-cd31-e053-dbdaa90ab51aPromescent
55636-590-742019-11-27C16284748780-19855d018-d2e6-cd31-e053-dbdaa90ab51aPromescent
55636-590-742019-11-27C16284748780-19855d018-d2e6-cd31-e053-dbdaa90ab51aPromescent

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LidocaineACTIVE INGREDIENT98PI2009871
LIDOCAINEACTIVE MOIETY98PI2009871
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
FARNESOLINACTIVE INGREDIENTEB41QIU6JL1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZ1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM621
MACADAMIA OILINACTIVE INGREDIENT515610SU8C1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
STEAROXYTRIMETHYLSILANEINACTIVE INGREDIENT9862TW94B21
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
THYMOLINACTIVE INGREDIENT3J50XA376E1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55636-59055636-590-74, 55636-590-52, 55636-590-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
STEAROXYTRIMETHYLSILANE9862TW94B2IACT
STEARYL ALCOHOL2KR89I4H1YIACT
MACADAMIA OIL515610SU8CIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
FARNESOLEB41QIU6JLIACT
THYMOL3J50XA376EIACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112026-02-09full-release2026-06-01 01:37:44

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 304 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YLOTION / TOPICAL1140 mgExact identifier — unii+route
20 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route
76 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
64 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
64 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YOINTMENT / TOPICAL569 mgExact identifier — unii+route
20 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii+route
64 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route
60 equally ranked IID candidates
THYMOLTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
8 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route
76 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
THYMOLTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
8 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii+route
60 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii+route
76 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route
76 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION, AUGMENTED / TOPICALADJ PHExact identifier — unii+route
76 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii+route
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii+route
76 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM, AUGMENTED / TOPICAL6 mgExact identifier — unii+route
76 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
24 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii+route
76 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
64 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route
24 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
24 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii+route
76 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / TOPICALADJ PHExact identifier — unii+route
76 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii+route
76 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
64 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route
60 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii+route
76 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
64 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route
60 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii+route
60 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYSPRAY / TOPICAL2.42 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route
60 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route
64 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
24 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii+route
60 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISHAMPOO / TOPICAL3 mgExact identifier — unii+route
76 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
64 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route
64 equally ranked IID candidates
THYMOLTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
8 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PromescentLIDICAINEAbsorption5b508238-3be7-4b0d-bf35-51de79f58f552026-06-30WarningsExact identifier
ndc (package): 55636-590-52
ndc (package): 55636-590-26
ndc (package): 55636-590-74
ndc (product): 55636-590
ndc11 (package): 55636059052
ndc11 (package): 55636059026
ndc11 (package): 55636059074
spl id: 5578bdd9-b03b-b909-e063-6294a90a0c79
spl set id: 5b508238-3be7-4b0d-bf35-51de79f58f55

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.