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RECTICARE

Ferndale Laboratories, Inc.

RECTICARE Lidocaine 5% Anorectal Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

RECTICARE 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


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

30 grams (NDC 0496-0892-30)

Back Carton Panel

RECTICARE

Front Carton Panels

RECTICARE

RECTICARE

lidocaine CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0496-0892
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LIDOCAINE LIDOCAINE 50 mg

Inactive Ingredients

Ingredient Name Strength
BENZYL ALCOHOL
CARBOMER HOMOPOLYMER TYPE C
CHOLESTEROL
LECITHIN, SOYBEAN
ISOPROPYL MYRISTATE
polysorbate 80
propylene glycol
water
TROLAMINE
ALPHA-TOCOPHEROL ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0496-0892-30 30 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2012-03-09


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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