484 - Rectal Care Cream

484 - Rectal Care Cream
SPL v2
SPL
SPL Set ID ce585082-ad39-4b6f-a756-0d9a81a13eb8
Routes
RECTAL TOPICAL
Published
Effective Date 2025-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Benzyl Alcohol Carbomer Cholesterol Hydrogenated Soybean Lecithin Isopropyl Myristate Polysorbate 80 Propylene Glycol Triethanolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-07

Description

Lidocaine 5.0%

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Lidocaine 5.0%

Use(s)

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.

Other Information

Store at 15º-30º C (59º-86º F)

Questions/comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Lidocaine 5.0%

Inactive Ingredients

benzyl alcohol, carbomer, cholesterol, hydrogenated

lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate,

triethanolamine, water

Principal Display Panel
Rectal Care Cream Label
Rectal Care Cream Carton
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

• symptoms clear up and return within a few days

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use(s)

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.

Other Information (Other information)

Store at 15º-30º C (59º-86º F)

Questions/comments (Questions/Comments)

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s) (Active ingredient(s))

Lidocaine 5.0%

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carbomer, cholesterol, hydrogenated

lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate,

triethanolamine, water

Principal Display Panel
Rectal Care Cream Label
Rectal Care Cream Carton
When Using This Product (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 (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

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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