Zensa by Alera Skin Care Products Inc. ZENSA- lidocaine cream

Zensa by

Drug Labeling and Warnings

Zensa by is a Otc medication manufactured, distributed, or labeled by Alera Skin Care Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 5%

Purpose

Topical Anaesthetic

Uses

• For the temporary relief of local discomfort associated with anorectal disorders
• For the temporary relief of pain, soreness, and burning

Warnings

​For external use only.

When using this product

• avoid contact with eyes
• do not exceed the recommended daily dosage unless directed by a physician
• 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

Stop use and ask a doctor if

• condition worsens or does not improve within 7 days
• bleeding occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Adults: when practical, cleanse the affected area with mild soap, and warm water and rinse thoroughly.  Gently dry by patting or blottig with toilet tissue or a soft cloth before application of this product.  Children under 12 years of age: consult a physician.
• Apply externally to the affected area up to 6 times daily

Other information

See enclosed consumer leaflet.

Store at 15°C to 30°C.  Protect from freezing

Inactive ingredients

Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Vitamin E Acetate, Purified Water

PRINCIPAL DISPLAY PANEL

​NDC: 69805-786-01​

​ZENSA

TOPICAL ANESTHETIC CREAM - ANORECTAL

WITH 5% LIDOCAINE

30 g

INGREDIENTS AND APPEARANCE

ZENSA 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69805-786
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 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69805-786-01	1 in 1 CARTON	01/04/2016
1		30 g 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	01/04/2016

Labeler - Alera Skin Care Products Inc. (202686093)

Registrant - Alera Skin Care Products Inc. (202686093)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs, Inc		926831603	manufacture(69805-786)