Active Ingredient
Lidocaine 5% w/w
Recticare Cream
FDA Label NDC 0496-0892
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ferndale Laboratories, Inc. for the product Recticare (NDC 0496-0892). 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, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Inactive Ingredients
benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate
Package Label
Manufactured for Ferndale Healthcare® Inc.
By Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A.
Toll free (888) 548-0900
www.ferndalehealthcare.com
15 grams (NDC 0496-0892-15)
30 grams (NDC 0496-0892-30)
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