Secondary Numb Lidocaine/phenylephrine Gel

Secondary Numb Lidocaine/phenylephrine Gel
SPL v2
SPL
SPL Set ID 0f13f7b5-e3b1-451e-a6d6-e7e15bd04443
Route
TOPICAL
Published
Effective Date 2022-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Aminomethylpropanol Water Benzyl Alcohol Caprylyl Glycol Carbomer Homopolymer, Unspecified Type Phenoxyethanol Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-10

Description

Lidocaine 5% Phenylephrine HCL 0.25%

Purpose

Local Anesthetic Vaso Constrictor


Medication Information

Purpose

Local Anesthetic

Vaso Constrictor

Description

Lidocaine 5% Phenylephrine HCL 0.25%

Uses

• Temporary relief of pain • Temporarily shrinks hemorrhoidal tissue • For the temporary relief of anorectal discomfort associated with hemorrhoids



Warnings

For external use only

Directions

Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed







Do Not Use

if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination

Questions?

1-844-782-2387

Package Labeling:

Inactive Ingredients

Aminomethylpropanol, Aqua, Benzyl Alcohol, Caprylyl Glycol, Carbomer, Phenoxyethanol, Propylene Glycol

When Using This Product

• do not put it into the rectum by using fingers or any mechanical device or applicator

Active ingredients (w/w)

Lidocaine 5% Phenylephrine HCL 0.25%

Stop Use and Ask A Doctor If

• bleeding occurs • condition worsens or does not improve within 7 days • redness, irritation, swelling, pain or other symptoms occur. If allergic  reaction to product occurs.

Keep Out of Reach of Children.

If swallowed, call poison control centre or get medical help right away

Ask A Doctor Before Use If You Are

• presently taking medicine for high blood pressure or depression


Structured Label Content

Uses

• Temporary relief of pain • Temporarily shrinks hemorrhoidal tissue • For the temporary relief of anorectal discomfort associated with hemorrhoids



Purpose

Local Anesthetic

Vaso Constrictor

Warnings

For external use only

Directions

Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed







Do Not Use (Do not use)

if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination

Questions?

1-844-782-2387

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Aminomethylpropanol, Aqua, Benzyl Alcohol, Caprylyl Glycol, Carbomer, Phenoxyethanol, Propylene Glycol

When Using This Product (When using this product)

• do not put it into the rectum by using fingers or any mechanical device or applicator

Active ingredients (w/w)

Lidocaine 5% Phenylephrine HCL 0.25%

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

• bleeding occurs • condition worsens or does not improve within 7 days • redness, irritation, swelling, pain or other symptoms occur. If allergic  reaction to product occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call poison control centre or get medical help right away

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)

• presently taking medicine for high blood pressure or depression


Advanced Ingredient Data


Raw Label Data

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