FDA.reportPublic FDA data

Healthwise Anorectal Pain Relief Spray

Manufacturer
Veridian Healthcare | DermaCare Research Labs, LLC
Effective date
2026-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:38

Label at a glance#

ProductHealthwise Anorectal Pain Relief
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

helps relieve the local itching and pain associated with anorectal disorders or inflammation

Dosage and administration

• when practical, cleanse the affected area with mild soap and warm water • rinse thoroughly and gently pat dry • spray affected area • wash hands after applying • replace cap after use • adults and children 12 years and older: apply externally to the affected area not more than 6 times daily • children under 12 years of age: ask  a doctor 

Storage and handling

Store out of direct sunlight, in a cool dry, well-ventilated area.  Do not store at temperature above 120F (49C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Lidocaine 5%

OTC - ACTIVE INGREDIENT SECTION

Purpose

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal) spray

Uses

INDICATIONS & USAGE SECTION

helps relieve the local itching and pain associated with anorectal disorders or inflammation

Warnings

WARNINGS SECTION

For external use only

FlammableKeep away from fire or flame.  Do not use while smokig.  Do not punture or incinerate.  Contents under presure

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

• rectal bleeding occurs

• condition worsens or does not improve within 7 days or clear up and reoccur within a few days

When using this product

OTC - WHEN USING SECTION

• avoid contact with eyes

• do not exceed recommended dosage unless directed by a doctor

• do not put this product into the rectum by using fingers or any mechanical device or applicator

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• when practical, cleanse the affected area with mild soap and warm water

• rinse thoroughly and gently pat dry

• spray affected area • wash hands after applying

• replace cap after use

• adults and children 12 years and older:apply externally to the affected area not more than 6 times daily

• children under 12 years of age: ask a doctor 

Other information

STORAGE AND HANDLING SECTION

Store out of direct sunlight, in a cool dry, well-ventilated area.  Do not store at temperature above 120F (49C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

 alcohol denat, aloe barbadensis leaf extract, carbomer, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, disodium EDTA, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water

PRINCIPAL DISPLAY PANEL 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2637486lidocaine 5 % Rectal SprayPSN3
2637486lidocaine 50 MG/ML Rectal SpraySCD3
2637486lidocaine 5 % Rectal SpraySY3

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
71101-069-01Healthwise Anorectal Pain Relief113 mL in 1 BOTTLESPRAY1133

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
71101-06971101-069-01

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
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHAMOMILEFGL3685T2XIACT
CUCUMBER FRUIT OILR81Y52NPCTIACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
CARBOMER0A5MM307FCIACT
TRIETHANOLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-11-25monthly-update2026-06-03 17:40:43

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
Healthwise Anorectal Pain ReliefLIDOCAINE 5%Veridian Healthcare19c24e1b-a31b-478b-a48b-c39bb4753ca72026-01-06WarningsExact identifier
ndc (package): 71101-069-01
ndc (product): 71101-069
ndc11 (package): 71101006901
spl id: 47bfbf3c-b659-fa61-e063-6294a90ae55e
spl set id: 19c24e1b-a31b-478b-a48b-c39bb4753ca7

Reported adverse events (FAERS/openFDA)#

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