RECTICARE- lidocaine and glycerin cloth

RECTICARE by

Drug Labeling and Warnings

RECTICARE by is a Otc medication manufactured, distributed, or labeled by Ferndale Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0496-0980
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/01/2016

Labeler - Ferndale Laboratories, Inc. (005320536)

Registrant - Ferndale Laboratories, Inc. (005320536)

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