Recticare (Lidocaine And Glycerin) Cloth [Ferndale Laboratories, Inc.] -

RECTICARE (LIDOCAINE AND GLYCERIN) CLOTH [FERNDALE LABORATORIES, INC.]
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NDC	0496-0980-65, 0496-0980-76
Set ID	2b94136a-4975-2925-e054-00144ff88e88
Category	HUMAN OTC DRUG LABEL
Packager	Ferndale Laboratories, Inc.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART346

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Active Ingredients

Lidocaine 5% w/w

Glycerin 20% w/w
Purpose

Lidocaine 5% w/w........................................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

benzyl alcohol, citric acid, purified water
Package Label

INGREDIENTS AND APPEARANCE

RECTICARE
lidocaine and glycerin cloth

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0496-0980-65	12 in 1 CARTON	01/01/2016
1	NDC:0496-0980-76	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	01/01/2016

Labeler - Ferndale Laboratories, Inc. (005320536)

Registrant - Ferndale Laboratories, Inc. (005320536)

Name	Address	ID/FEI	Business Operations
Establishment
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0980)

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