zensa - 5% lidocaine cream

SPL v8

SPL

SPL Set ID f56146b6-3c11-4608-a6ab-6142f27e9ac3

Route

topical

Published

Effective Date 2022-09-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

lidocaine (5 g)

Inactive Ingredients

benzyl alcohol carbomer homopolymer type b (allyl pentaerythritol crosslinked) lecithin, soybean propylene glycol .alpha.-tocopherol acetate water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2016-01-04

Purpose

Topical Anaesthetic

Description

Lidocaine 5%

Medication Information

Warnings

For external use only.

Uses

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

Purpose

Topical Anaesthetic

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

Description

Lidocaine 5%

Active Ingredient

Lidocaine 5%

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

Principal Display Panel 1 Oz Tube Carton

zensa

LIDOCAINE CREAM

WITH 5% LIDOCAINE

alera SKINCARE

NDC 69805-786-01

1 oz

Structured Label Content

Warnings

For external use only.

Uses

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

Purpose

Topical Anaesthetic

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 (Other information)

See enclosed consumer leaflet.

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

Inactive Ingredients (Inactive ingredients)

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

Active Ingredient (Active ingredient)

Lidocaine 5%

When Using This Product (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 (Stop use and ask a doctor if)

condition worsens or does not improve within 7 days
bleeding occurs

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

Principal Display Panel 1 Oz Tube Carton (PRINCIPAL DISPLAY PANEL - 1 oz Tube Carton)

zensa

LIDOCAINE CREAM

WITH 5% LIDOCAINE

alera SKINCARE

NDC 69805-786-01

1 oz

Advanced Ingredient Data

[{"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of local discomfort associated with anorectal disorders For the temporary relief of pain, soreness, and burning", "Purpose": "Topical Anaesthetic", "Warnings": "For external use only.", "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", "Active ingredient": "Lidocaine 5%", "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", "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", "PRINCIPAL DISPLAY PANEL - 1 oz Tube Carton": "zensa LIDOCAINE CREAM WITH 5% LIDOCAINE alera SKINCARE NDC 69805-786-01 1 oz"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.180935 · Updated: 2026-03-14T23:05:22.628914