Rectal Care

Rectal Care
SPL v2
SPL
SPL Set ID a05d5e07-ae4b-38cc-e053-2a95a90abced
Route
TOPICAL
Published
Effective Date 2020-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Polysorbate 80 Cholesterol Hydrogenated Soybean Lecithin Isopropyl Myristate Propylene Glycol Water Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-09

Description

Lidocaine 5.0%


Medication Information

Warnings and Precautions

For external use only.

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.

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, or symptoms clear up and return within a few days.

Dosage and Administration
  • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a 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 a finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area
Description

Lidocaine 5.0%

Uses

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

Section 50565-1

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

Section 51945-4

Section 55105-1

Local Anesthetic

Section 55106-9

Lidocaine 5.0%


Structured Label Content

Uses

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

Dosage and Administration (34068-7)
  • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a 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 a finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area
Warnings and Precautions (34071-1)

For external use only.

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.

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, or symptoms clear up and return within a few days.

Section 50565-1 (50565-1)

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Local Anesthetic

Section 55106-9 (55106-9)

Lidocaine 5.0%


Advanced Ingredient Data


Raw Label Data

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