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 4.3% w/w (as 5% lidocaine HCl)

Glycerin 20% w/w

Purpose

Lidocaine 4.3% w/w (as 5% lidocaine HCl)...Local anesthetic

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

Uses

helps relieve the pain, itching and burning associated with anorectal disorders
temporarily provides a coating for relief of anorectal discomforts
temporarily protects irritated and inflamed perianal skin

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

when practical, cleanse the affected area with mild soap and warm water and rinse thoroghly
gently apply wipe to the affected area by patting and then discard
adults and children 12 years & older: apply up to 6 times daily - or after each bowel movement
children under 12 years: consult a doctor

Inactive Ingredients

citric acid, sodium citrate, potassium sorbate, phenoxyethanol, purified water

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

12 Count Carton NDC 0496-0977-65

RecticareWipeCarton

RECTICARE
lidocaine and glycerin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0496-0977
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	43 mg in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0496-0977-65	12 in 1 CARTON	01/15/2015	01/01/2018
1	NDC:0496-0977-76	6 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	01/15/2015	01/01/2018

Labeler - Ferndale Laboratories, Inc. (005320536)

Name	Address	ID/FEI	Business Operations
Establishment
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0977)

Revised: 1/2018

Document Id: 60c9d8b7-e09c-5532-e053-2a91aa0a2adb

Set id: 81d65f3b-6dd4-4114-a638-de8b313c5d36

Version: 8

Effective Time: 20180104

Ferndale Laboratories, Inc.