Lubricaine 5 - DailyMed Details

Lubricaine 5

SPL v5

SPL

SPL Set ID 9d98afbf-11ce-745b-e053-2a95a90abc14

Route

TOPICAL

Published

Effective Date 2019-03-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Lidocaine (0.72 g)

Inactive Ingredients

Benzyl Alcohol Chamomile Flower Oil Lactic Acid, Dl- Allantoin Stevia Rebaudiuna Leaf Glycerin Propanediol Xanthan Gum Dehydroacetic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-03-20

Description

Lidocaine 5%

Purpose

Anorectal Anesthetic

Medication Information

Purpose

Anorectal Anesthetic

Description

Lidocaine 5%

Uses

For temporary relief of pain, soreness or burning in the perianal area

Section 51945-4

Warnings

For external use only.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am -5 pm Eastern Time M-F or visit www.esbalabs.com.

Directions

Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application.
Apply externally to the affected area up to 6 times daily.

Active Ingredient

Lidocaine 5%

Other Information

Store at room temperature 20-25oC (68-77oF).
Tamper Evident: do not use if seal under cap is broken or missing.
Child-Resistant Cap: push down and turn to open.

Inactive Ingredients

Allantoin, Anthemis Nobilis (Roman Chamomile) Essential Oil, Benzyl Alcohol, Dehydroacetic Acid, Glycerin, Lactic Acid, Propanediol, Purified Water, Stevia Rebaudiana Extract, Xanthan Gum.

When Using This Product

Do not use this product with a mechanical device. Certain persons can develop allergic reactions to ingredients in this product.

Stop Use and Ask A Doctor If

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 exceed the daily recommended dosage.
In case of bleeding, consult a doctor promptly.
As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.

Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Structured Label Content

Uses

For temporary relief of pain, soreness or burning in the perianal area

Section 51945-4 (51945-4)

Purpose

Anorectal Anesthetic

Warnings

For external use only.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am -5 pm Eastern Time M-F or visit www.esbalabs.com.

Directions

Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application.
Apply externally to the affected area up to 6 times daily.

Active Ingredient

Lidocaine 5%

Other Information

Store at room temperature 20-25oC (68-77oF).
Tamper Evident: do not use if seal under cap is broken or missing.
Child-Resistant Cap: push down and turn to open.

Inactive Ingredients

Allantoin, Anthemis Nobilis (Roman Chamomile) Essential Oil, Benzyl Alcohol, Dehydroacetic Acid, Glycerin, Lactic Acid, Propanediol, Purified Water, Stevia Rebaudiana Extract, Xanthan Gum.

When Using This Product (When using this product)

Do not use this product with a mechanical device. Certain persons can develop allergic reactions to ingredients in this product.

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

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 exceed the daily recommended dosage.
In case of bleeding, consult a doctor promptly.
As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.

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

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Advanced Ingredient Data

[{"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "0.72", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CHAMOMILE FLOWER OIL", "unii": "60F80Z61A9", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "LACTIC ACID, DL-", "unii": "3B8D35Y7S4", "classCode": "IACT", "strengthNumerator": "2.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "STEVIA REBAUDIUNA LEAF", "unii": "6TC6NN0876", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PROPANEDIOL", "unii": "5965N8W85T", "classCode": "IACT", "strengthNumerator": "38.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "DEHYDROACETIC ACID", "unii": "2KAG279R6R", "classCode": "IACT", "strengthNumerator": "0.08", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For temporary relief of pain, soreness or burning in the perianal area", "Purpose": "Anorectal Anesthetic", "Warnings": "For external use only.", "Questions": "Call toll-free in USA & Canada 800-677-9299 9 am -5 pm Eastern Time M-F or visit www.esbalabs.com .", "Directions": "Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application. Apply externally to the affected area up to 6 times daily.", "Active Ingredient": "Lidocaine 5%", "Other Information": "Store at room temperature 20-25oC (68-77oF). Tamper Evident: do not use if seal under cap is broken or missing. Child-Resistant Cap: push down and turn to open.", "Inactive Ingredients": "Allantoin, Anthemis Nobilis (Roman Chamomile) Essential Oil, Benzyl Alcohol, Dehydroacetic Acid, Glycerin, Lactic Acid, Propanediol, Purified Water, Stevia Rebaudiana Extract, Xanthan Gum.", "When using this product": "Do not use this product with a mechanical device. Certain persons can develop allergic reactions to ingredients in this product.", "Stop use and ask a doctor if": "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 exceed the daily recommended dosage. In case of bleeding, consult a doctor promptly. As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.", "Keep out of the reach of children": "If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:27.236136 · Updated: 2026-03-14T23:12:39.597935