RECTICARE- lidocaine and glycerin cloth 
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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RectiCare Medicated Anorectal Wipes

Active Ingredients

Lidocaine 5% w/w

Glycerin 20% w/w

Purpose

Lidocaine 5% w/w........................................Local anesthetic

Glycerin 20% w/w.........................................Protectant

Uses

Warnings

For external use only

Do not

  • exceed the recommended daily dosage unless directed by a doctor
  • put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • an allergic reaction develops
  • condition worsens or does not improve witin 7 days
  • redness, irriation, swelling, pain or other symptoms begin or increase
  • bleeding occurs

Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center right away.

Directions

Inactive Ingredients

benzyl alcohol, citric acid, purified water

Package Label

frontpouch

pouchback

RECTICARE 
lidocaine and glycerin cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0980
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0496-0980-6512 in 1 CARTON01/01/2016
1NDC:0496-0980-766 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2016
Labeler - Ferndale Laboratories, Inc. (005320536)
Registrant - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture(0496-0980)

Revised: 11/2019
Document Id: 97a52156-d456-c339-e053-2a95a90a0334
Set id: 2b94136a-4975-2925-e054-00144ff88e88
Version: 2
Effective Time: 20191118
 
Ferndale Laboratories, Inc.