equate hemorrhoid relief cream- lidocaine 5%

equate hemorrhoid relief cream- lidocaine 5%
SPL v6
SPL
SPL Set ID d96e8152-e36e-22fc-e053-2995a90a8b2b
Route
topical
Published
Effective Date 2022-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (50 mg)
Inactive Ingredients
propylene glycol water polysorbate 80 trolamine hydrogenated soybean lecithin benzyl alcohol carbomer 940 alpha-tocopherol acetate cholesterol isopropyl myristate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-04-01

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 anorectal disorders.

Purpose

Local Anesthetic

Directions

Adult and children 12 years and over:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • apply externally to the affected area up to 6 times a day

children under 12 years of age: consult a doctor.

Other Information

Store between 15°-30° C (59°-30° F)

Inactive Ingredients

Benzyl Alcohol, Carbomer 940, Cholesterol, Isopropyl Myristate, Lecithin (Soya), Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin-E Acetate

Description

Lidocaine 5% W/W

Principal Display Panel

Questions

1-888-287-1915

Active Ingredient

Lidocaine 5% W/W

When Using This Product
  • use only as directed
  • 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
Stop Use and Ask A Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and occur again within a few days
  • an allergic reaction develops to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children and Pets.

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


Structured Label Content

Warnings (WARNINGS)

For external use only

Uses (USES)

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

Purpose (PURPOSE)

Local Anesthetic

Directions (DIRECTIONS)

Adult and children 12 years and over:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • apply externally to the affected area up to 6 times a day

children under 12 years of age: consult a doctor.

Other Information (OTHER INFORMATION)

Store between 15°-30° C (59°-30° F)

Inactive Ingredients (INACTIVE INGREDIENTS)

Benzyl Alcohol, Carbomer 940, Cholesterol, Isopropyl Myristate, Lecithin (Soya), Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin-E Acetate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions (QUESTIONS)

1-888-287-1915

Active Ingredient (ACTIVE INGREDIENT)

Lidocaine 5% W/W

When Using This Product (When using this product)
  • use only as directed
  • 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
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
  • symptoms clear up and occur again within a few days
  • an allergic reaction develops to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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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