FDA.reportPublic FDA data

Nite

Manufacturer
Nite Storm LLC
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:50:33

Label at a glance#

ProductNite
Active ingredientHYDROXYETHYL CELLULOSE (140 CPS AT 5%)
Label structure11 sections

Label contents#

Full prescribing information#

Usage:

INDICATIONS & USAGE SECTION

Gently squeeze out an appropriate amount of lubricant, and evenly apply it on the desired area.

Description

DESCRIPTION SECTION

NITE "After Hours" is an organic aloe-based personal lubricant for penile and /or vaginal application. Intended to moisturize and lubricate, enhance the ease and comform of initimate secual activity, and supplement the body's natural lubrication. Natural feel caused only by natural ingredients.

Warning:

WARNINGS SECTION

If irritaiton or discomfort occurs, discontinue use immediately and consult a physician.

Keep out of eyes and ears.

Keep out of reach of Children and pets.

Very slippery, clean spills immediately.

This product is not a contraceptive or spermicide.

Bottle may leak if not stored upright.

Store at ambient weather.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Apply a small amount to genital areas. Reapply as needed or desired.

Stop Use

OTC - STOP USE SECTION

If irritation or discomfort occurs, discontinue the use and consult a physician. Very slippery on surfaces, clean spills immediately.

Ask doctor

OTC - ASK DOCTOR SECTION

If irritation or discomfort occurs, discontinue the use and consult a physician

Purpose:

OTC - PURPOSE SECTION

NITE "After Hours" is an organic aloe-based personal lubricant for penile and/or vaginal appliation. Intended to moisturize and lubricate, enhance the ease and comfort of initimate secual activity.

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

HYDROXYETHYL CELLULOSE

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

HYDROXYETHYL CELLULOSE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85094-708-01Nite75 mL in 1 TUBEOIL751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85094-708NITE (PERSONAL LUBRICANT LOTION) OIL [NITE STORM LLC]1Current NDC, 1 package rows20250104_2aa6ed27-6b90-92c2-e063-6394a90a2a12.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85094-70885094-708-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)8136Y38GY5ACTIB

Source Document#

Source XML

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
NitePERSONAL LUBRICANT LOTIONNite Storm LLC2aa6ed27-6b90-92c2-e063-6394a90a2a122025-01-01WarningsExact identifier
ndc (package): 85094-708-01
ndc (product): 85094-708
ndc11 (package): 85094070801
spl id: 2aa6ed27-6b91-92c2-e063-6394a90a2a12
spl set id: 2aa6ed27-6b90-92c2-e063-6394a90a2a12

Reported adverse events (FAERS/openFDA)#

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