RECTICARE - lidocaine cream 
Ferndale Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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


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)

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RECTICARE 
lidocaine cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0496-0892
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 50 mg  in 1 g
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
1 NDC:0496-0892-30 30 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 03/09/2012
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
Name Address ID/FEI Business Operations
Ferndale Laboratories, Inc. 005320536 manufacture

Revised: 03/2012
Ferndale Laboratories, Inc.