SPL v3
SPL
SPL Set ID ce3ffebf-e3c0-47c2-b8cf-ecce4ef8c51d
Route
TOPICAL
Published
Effective Date 2023-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Poloxamer 124 Aloe Vera Leaf Benzalkonium Chloride Disodium Ethylenediaminediacetate Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-07
Description

Lidocane hydrochloride, 4%

Purpose

Pain reliever

Medication Information

Purpose

Pain reliever

Description

Lidocane hydrochloride, 4%

Uses

For the temporary relief of pain and/or itching associated with minor skin irritations

Section 42229-5

Questions? 1-888-420-2326

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a poison control center immediately.

Section 50566-9

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Section 50567-7

When using this product avoid contact with the eyes.  In case of eye contact, flush eyes with water.

Section 50570-1

Do not use in large quantities, particularly on raw surfaces of blistered areas.

Section 51945-4

H2Ocean(r)

First In First Aid (TM)

NOTHING (TM)

Pain Relieving Soap with Lidocaine

Anesthetic

1.7 Fl. Oz. (50 ml.)

Warnings

For external use only

Directions

Adults and children 2 years of age and older:  Apply 1-2 pumps of the foam soap to the affected area 3-4 times daily.

Children under 2 years of age: consult a doctor.

For best results, do not use with alcohol based products.

Active Ingredient

Lidocane hydrochloride, 4%

Inactive Ingredients

Purified water, Poloxamer, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Disodium ETDA, Sea Salt

Structured Label Content

Uses

For the temporary relief of pain and/or itching associated with minor skin irritations

Section 42229-5 (42229-5)

Questions? 1-888-420-2326

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes.  In case of eye contact, flush eyes with water.

Section 50570-1 (50570-1)

Do not use in large quantities, particularly on raw surfaces of blistered areas.

Section 51945-4 (51945-4)

H2Ocean(r)

First In First Aid (TM)

NOTHING (TM)

Pain Relieving Soap with Lidocaine

Anesthetic

1.7 Fl. Oz. (50 ml.)

Purpose

Pain reliever

Warnings

For external use only

Directions

Adults and children 2 years of age and older:  Apply 1-2 pumps of the foam soap to the affected area 3-4 times daily.

Children under 2 years of age: consult a doctor.

For best results, do not use with alcohol based products.

Active Ingredient

Lidocane hydrochloride, 4%

Inactive Ingredients

Purified water, Poloxamer, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Disodium ETDA, Sea Salt

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:10.692592 · Updated: 2026-03-14T23:01:36.166619