Rectalief Lidocaine 5 Cream

Rectalief Lidocaine 5 Cream
SPL v1
SPL
SPL Set ID 2c262f3c-8cb2-4384-e063-6294a90a436d
Route
TOPICAL
Published
Effective Date 2025-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.05 g)
Inactive Ingredients
Tocopherol Benzyl Alcohol Aloe Barbadensis Leaf Juice Cholesterol Isopropyl Myristate Mineral Oil Propylene Glycol Trolamine Polysorbate 80 Water Carbomer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-20
Description

Lidocaine 5% W/W

Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY

Indications and Usage

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

Description

Lidocaine 5% W/W

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and occur again within a few days
Section 50567-7

When using this product

  • avoid contact with eyes
  • do not use more than directed unless directed by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Section 51727-6

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine.

Section 51945-4

NDC 69618-075-78

Reliable 1 Laboratories

Rectalief

Anorectal Cream

Lidocaine 5%

Relieves Pain, Itching & Burning

Highest Strength of Non-Rx Lidocaine Available

1OZ (30gm)

QUESTIONS

1-516-341-0666 Monday- Friday

Distributed by

Reliable 1 Labs

99 W. Hawthorne Ave #610

Valley Stream, NY 11580

www.reliable1labs.com

Made in China

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Local Anesthetic Anorectal (Hemorrhoidal) Cream

Section 55106-9

Lidocaine 5% W/W

Section 60561-8

Store between 20°-25° C (68°-77° F)

Directions
  • 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 applying
  • Adults and children 12 years of age and older: apply externally to the affected area not more than 6 times a day.
  • children under 12 years of age: consult a doctor.

Structured Label Content

Indications and Usage (34067-9)

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

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • do not use more than directed unless directed by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Section 51727-6 (51727-6)

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine.

Section 51945-4 (51945-4)

NDC 69618-075-78

Reliable 1 Laboratories

Rectalief

Anorectal Cream

Lidocaine 5%

Relieves Pain, Itching & Burning

Highest Strength of Non-Rx Lidocaine Available

1OZ (30gm)

QUESTIONS

1-516-341-0666 Monday- Friday

Distributed by

Reliable 1 Labs

99 W. Hawthorne Ave #610

Valley Stream, NY 11580

www.reliable1labs.com

Made in China

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Local Anesthetic Anorectal (Hemorrhoidal) Cream

Section 55106-9 (55106-9)

Lidocaine 5% W/W

Section 60561-8 (60561-8)

Store between 20°-25° C (68°-77° F)

Directions (DIRECTIONS)
  • 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 applying
  • Adults and children 12 years of age and older: apply externally to the affected area not more than 6 times a day.
  • children under 12 years of age: consult a doctor.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:23.063477 · Updated: 2026-03-14T23:07:05.651363