Healthwise Anorectal Pain Relief Spray

Healthwise Anorectal Pain Relief Spray
SPL v3
SPL
SPL Set ID 19c24e1b-a31b-478b-a48b-c39bb4753ca7
Route
TOPICAL
Published
Effective Date 2026-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Edetate Disodium Propylene Glycol Water Alcohol Glycerin Aloe Barbadensis Leaf .alpha.-tocopherol Acetate Chamomile Cucumber Fruit Oil Disodium Cocoamphodipropionate Carbomer Triethanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Drug Facts

Purpose

Anorectal (hemorrhoidal) spray


Medication Information

Purpose

Anorectal (hemorrhoidal) spray

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Warnings

For external use only

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

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

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

Principal Display Panel 

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

Keep Out of Reach of Children.

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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Anorectal (hemorrhoidal) spray

Warnings

For external use only

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

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 (Other information)

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

Inactive Ingredients (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

When Using This Product (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

Principal Display Panel  (PRINCIPAL DISPLAY PANEL )

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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