HEALTHWISE ANORECTAL PAIN RELIEF- lidocaine 5% spray

Healthwise Anorectal Pain Relief by

Drug Labeling and Warnings

Healthwise Anorectal Pain Relief by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, DermaCare Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Lidocaine 5%

Purpose

Anorectal (hemorrhoidal)

Uses

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

Warnings

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

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

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.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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

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

Inactive ingredients

 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 

INGREDIENTS AND APPEARANCE

HEALTHWISE ANORECTAL PAIN RELIEF 
lidocaine 5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
CARBOMER (UNII: 0A5MM307FC)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-069-01	113 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	11/01/2025

Labeler - Veridian Healthcare (830437997)

Registrant - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
DermaCare Research Labs, LLC		116817470	manufacture(71101-069)