maximum strength hemorrhoidal relief cream

maximum strength hemorrhoidal relief cream
SPL v3
SPL
SPL Set ID b61424bf-3b23-420b-a7bc-256ddb96aa22
Route
topical
Published
Effective Date 2022-01-31
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 2022-06-01

Purpose

Local anesthetic

Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%


Medication Information

Warnings

For external use only.

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

Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Questions?

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

Use

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

Package Labeling:

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

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

Warnings

For external use only.

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

Questions?

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

Use

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

Package Labeling:

Active Ingredients (Active ingredients)

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

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.


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