Request Item

RECTASMOOTHE CREAM (OTC) 0.05 30GM

Generic: Lidocaine 5%

NDC:69315-0301-30

Manufacturer:Leading Pharma, LLC

Strength:5 g/100g

Dosage Form:CREAM

Route:TOPICAL

Licensed pharmacies, clinics, doctor's offices, and veterinary practices get instant account approval

Drug Information

Identification

Generic Name

Lidocaine 5%

Brand Name

RectaSmoothe

Labeler / Distributor

Leading Pharma, LLC

Product Type

HUMAN OTC DRUG

Administration

Dosage Form

CREAM

Route of Administration

TOPICAL

FDA Application Number

part346

Active Ingredients

Ingredient	Strength
LIDOCAINE	5 g/100g

Pharmacological Class

Amide Local AnestheticAmides [CS]AntiarrhythmicLocal Anesthesia [PE]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documents DSCSA compliance resource hub

Drug Resources

Lidocaine 5% Drug Page NDC 69315-0301-30 Lookup

Clinical Drug Information

Indications & Usage

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

Warnings

WARNINGS: For external use only. When using this product avoid contact with the eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any other mechanical device or applicator Stop use and ask 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 suside or if redness, irritation swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions When practical, clean area with mild soap and warm water and rinse thouroughly. 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 six times a day. Children under 12 years of age: Consult a doctor To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.