ZENSA NUMBING GEL- lidocaine 5%, phenylephrine hydrochloride 0.25% gel

Zensa Numbing Gel by

Drug Labeling and Warnings

Zensa Numbing Gel 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% and Phenylephrine hydrochloride 0.25%

PURPOSE

Local Anaesthetic

Vasoconstrictor

Protective

USES

For temporary relief of local discomfort associated with anorectal disorders. For temporary
relief of pain, soreness and burning. Temporarily shrinks hemorrhoidal tissue.

WARNINGS

For external use only.

Before use ask a doctor:
if you are presently taking a prescription drug for high blood pressure or depression.

When using this product:

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.

Do not use this product if you have
heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland
unless directed by 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

Children under 12 years of age: Consult a doctor.

Apply externally to the affected area up to 4 times daily.

STORAGE AND HANDLING

Other Information

See enclosed consumer leaflet prior to use. Store at 59°-86°F.
Protect from freezing.

INACTIVE INGREDIENT

Benzyl Alcohol, Carbomer, Caprylyl Glycol, Propylene Glycol, Phenoxyethanol, Purified Water.

QUESTIONS

Questions? 1-844-441-7546

Zensa Numbing Gel 1 oz

INGREDIENTS AND APPEARANCE

ZENSA NUMBING GEL 
lidocaine 5%, phenylephrine hydrochloride 0.25% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69805-400
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69805-400-01	1 in 1 CARTON	09/25/2023
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 Drug	M015	09/25/2023

Labeler - Alera Skin Care Products Inc. (202686093)