Maximum Strength Hemorrhoidal Relief Cream With Finger Cots Kit

Maximum Strength Hemorrhoidal Relief Cream With Finger Cots Kit
SPL v3
SPL
SPL Set ID 82aa128a-44cd-4907-b0f7-8a31e086d3e6
Route
TOPICAL
Published
Effective Date 2022-06-30
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 Trolamine .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-08

Description

Lidocaine 5% w/w

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Lidocaine 5% w/w

Uses

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

Warnings

For external use only.

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.
Drug Facts

Questions?

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

Active Ingredient

Lidocaine 5% w/w

Other Information

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

Package Labeling:

Inactive Ingredients

aloe oil, benzyl alcohol, carbomer 940, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purified water, trolamine, vitamin E

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 right away.


Structured Label Content

Uses

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

Purpose

Local anesthetic

Warnings

For external use only.

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.
Drug Facts

Questions?

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

Active Ingredient (Active ingredient)

Lidocaine 5% w/w

Other Information (Other information)

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

Package Labeling:

Inactive Ingredients (Inactive ingredients)

aloe oil, benzyl alcohol, carbomer 940, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purified water, trolamine, vitamin E

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 right away.


Advanced Ingredient Data


Raw Label Data

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