SPL v1
SPL
SPL Set ID 065a6eec-3896-0da8-e063-6394a90a849d
Route
RECTAL
Published
Effective Date 2023-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (0.25 g) Lidocaine (5 g)
Inactive Ingredients
Caprylyl Glycol Propylene Glycol Benzyl Alcohol Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-25

Description

Lidocaine 5% and Phenylephrine hydrochloride 0.25%

Purpose

Local Anaesthetic Vasoconstrictor Protective

Storage and Handling

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


Medication Information

Purpose

Local Anaesthetic

Vasoconstrictor

Protective

Storage and Handling

Other Information

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

Protect from freezing.

Description

Lidocaine 5% and Phenylephrine hydrochloride 0.25%

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.

Questions

Questions? 1-844-441-7546

Directions

Children under 12 years of age: Consult a doctor.

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

Active Ingredient

Lidocaine 5% and Phenylephrine hydrochloride 0.25%

Inactive Ingredient

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

Zensa Numbing Gel 1 Oz

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If:

•condition worsens or does not improve within 7 days

•bleeding occurs.


Structured Label Content

Uses (USES)

For temporary relief of local discomfort associated with anorectal disorders. For temporary

relief of pain, soreness and burning. Temporarily shrinks hemorrhoidal tissue.

Purpose (PURPOSE)

Local Anaesthetic

Vasoconstrictor

Protective

Warnings (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.

Questions (QUESTIONS)

Questions? 1-844-441-7546

Directions (DIRECTIONS)

Children under 12 years of age: Consult a doctor.

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

Active Ingredient

Lidocaine 5% and Phenylephrine hydrochloride 0.25%

Inactive Ingredient (INACTIVE INGREDIENT)

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

Storage and Handling (STORAGE AND HANDLING)

Other Information

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

Protect from freezing.

Zensa Numbing Gel 1 Oz (Zensa Numbing Gel 1 oz)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

•condition worsens or does not improve within 7 days

•bleeding occurs.


Advanced Ingredient Data


Raw Label Data

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