FDA.reportPublic FDA data

WAXUP Numbing Spray

Manufacturer
CONSTRUSOLUTION, LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:57

Label at a glance#

ProductWAXUP Numbing
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

Helps relieve the local itching and discomfort in the perianal area For the temporary relief of pain, irritation or burning.

Dosage and administration

Adults:• When practical, cleanse the affected area "with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years of age: consult a doctor. • Apply externally to the affected area up to 6 times daily or after each bowel movement.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 5.00%

Purpose

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal)

Uses:

INDICATIONS & USAGE SECTION

  • Helps relieve the local itching and discomfort in the perianal area
  • For the temporary relief of pain, irritation or burning.

Warnings:

WARNINGS SECTION

For external use only.

Do not:

OTC - DO NOT USE SECTION

  • exceed the recommended daily dosage unless directed by a doctor.
  • put this product into the rectum by using fingers or any mechanical device or applicator.

When using this product:

OTC - WHEN USING SECTION

  • If condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
  • Certain persons can develop allergic reactions to ingredients in this product.

Allergy alert: 

Keep out of raech of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults:• When practical, cleanse the affected area "with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years of age: consult a doctor. • Apply externally to the affected area up to 6 times daily or after each bowel movement.

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Ethylhexylglycerin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2624687lidocaine HCl 5 % Rectal SprayPSN2
2624687lidocaine hydrochloride 50 MG/ML Rectal SpraySCD2
2624687lidocaine hydrochloride 5 % Rectal SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83163-386-00WAXUP Numbing1 in 1 BOXLIQUID12
83163-386-00WAXUP Numbing59.14 mL in 1 BOTTLE, SPRAYLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83163-386WAXUP NUMBING (LIDOCAINE HYDROCHLORIDE) LIQUID [CONSTRUSOLUTION, LLC]2Current NDC, Legacy NDC, 2 package rows20231106_4f1645ab-1b19-4d69-99c3-9ea275b01a87.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83163-38683163-386-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
CORN0N8672707OIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
WAXUP NumbingLIDOCAINE HYDROCHLORIDECONSTRUSOLUTION, LLC4f1645ab-1b19-4d69-99c3-9ea275b01a872023-11-06WarningsExact identifier
ndc (package): 83163-386-00
ndc (product): 83163-386
ndc11 (package): 83163038600
spl id: 0976ef49-eccc-1b67-e063-6294a90a4ec6
spl set id: 4f1645ab-1b19-4d69-99c3-9ea275b01a87

Reported adverse events (FAERS/openFDA)#

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