ANORECTAL- lidocaine cream

Anorectal by

Drug Labeling and Warnings

Anorectal by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Product Quest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                               Purpose

Lidocaine 5%......................................Local anesthetic

PURPOSE

INDICATIONS & USAGE

Uses For temporary relief of pain, soreness and burning.

WarningsFor external use only

When using this product do not get into eyes.
Stop use and ask a doctor if condition worsens or does
not improve within 7 days do not exceed the
recommended daily dosage unless directed by a doctor
in case of bleeding, consult a doctor promptly do not
put this product into the rectum by using fingers or any
mechanical device or applicator

Certain persons can develop allergic reactions to ingredients in this
product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or
increase, discontinue use and consult a doctor

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

DOSAGE & ADMINISTRATION

Directions Apply externally to affected area up to 6 times daily. Gently dry by patting or blotting with tissue or a soft
cloth before application of this product. 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 SAFETY INFORMATION

Other information Store at 25° C (77° F);
excursions permitted to 15-30˚ C (59-86˚ F).

INACTIVE INGREDIENT

Inactive ingredients
Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANORECTAL 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	Lidocaine	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Benzyl alcohol (UNII: LKG8494WBH)
Cholesterol (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Trolamine (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1234-1	1 in 1 CARTON	03/24/2016
1		28.3 mL in 1 TUBE; 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	03/24/2016

Labeler - Rite Aid (014578892)

Registrant - Product Quest (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest		927768135	manufacture(11822-1234) , label(11822-1234)