leader maximum strength hemorrhoidal relief cream

leader maximum strength hemorrhoidal relief cream
SPL v2
SPL
SPL Set ID 65c780b0-7f47-4ae9-a847-c22deaaa2888
Route
topical
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (50 mg)
Inactive Ingredients
benzyl alcohol carbomer homopolymer type c (allyl pentaerythritol crosslinked) cholesterol isopropyl myristate mineral oil polysorbate 80 propylene glycol water sodium hydroxide .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-01

Purpose

Local anesthetic

Description

Lidocaine 5% w/w


Medication Information

Warnings

For external use only.

Uses

helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Purpose

Local anesthetic

Directions
  • when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • adults and children 12 years and older: apply externally to the affected area up to 6 times a day. 
  • children under 12 years of age: consult a doctor
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Other Information

store at room temperature 68° - 77° F (20° - 25° C)

Inactive Ingredients

aloe vera oil, benzyl alcohol, carbomer homopolymer, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purifed water, sodium hydroxide, vitamin E

Description

Lidocaine 5% w/w

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Package Labeling:

When Using This Product
  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase 
  • symptoms clear up and return 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

Warnings

For external use only.

Uses

helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Purpose

Local anesthetic

Directions
  • when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • adults and children 12 years and older: apply externally to the affected area up to 6 times a day. 
  • children under 12 years of age: consult a doctor
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Other Information (Other information)

store at room temperature 68° - 77° F (20° - 25° C)

Inactive Ingredients (Inactive ingredients)

aloe vera oil, benzyl alcohol, carbomer homopolymer, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purifed water, sodium hydroxide, vitamin E

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Drug Facts

Active Ingredient (Active ingredient)

Lidocaine 5% w/w

Package Labeling:

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

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
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase 
  • symptoms clear up and return 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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