Family Wellness Anorectal Lidocaine Cream
FDA Label NDC 55319-826

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Family Wellness Anorectal Lidocaine (NDC 55319-826). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, if pregnant or breastfeeding,ask a health professional before use., directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ If Pregnant Or Breastfeeding,ask A Health Professional Before Use.

→ Directions

→ Other Information

→ Inactive Ingredient

→ Questions 1-800-814-8028

→ Principal Display Panel -tube

→ Principal Display Panel -carton

Active Ingredient

Lidocaine 5 % w/w

Purpose

Local Anesthetic

Uses

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

Warnings

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
symptoms clear up and return within a few days

If Pregnant Or Breastfeeding,Ask A Health Professional Before Use.

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 controlled room temperature 68-77° F (20-25 °C)

Inactive Ingredient

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate