SPL v3
SPL
SPL Set ID 3c19aff8-fb18-78d0-e063-6294a90a9481
Route
TOPICAL
Published
Effective Date 2025-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Safflower Oil Chondrus Crispus Hypericum Perforatum Whole Aloe Vera Leaf Soybean Oil Matricaria Chamomilla Sodium Polyacrylate (8000 Mw) Arnica Montana Caprylic/capric Triglyceride Phenoxyethanol Achillea Millefolium Whole Tocopherol Shea Butter Polyacrylic Acid (800000 Mw) Coconut Oil Water Sodium Hydroxide Helianthus Annuus (sunflower) Seed Wax Echinacea, Unspecified

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Active ingredients: Purpose Lidocaine HCl 4% .........................Topical Anesthetic


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • For the temporary relief of pain.
  • Also relieves itching associated with minor burns, sunburn, minor cuts, scrapes, inspect bites, minor skin irritations and rashes due to poison ivy.
Dosage and Administration

Directions:

Twist off cap and remove foil seal.

Adults and children 4 years of age and

older: Apply to affected area not more than 3 to

4 times daily.

Children under 4 years of age: do not use,

consult a doctor.

Description

Active ingredients: Purpose Lidocaine HCl 4% .........................Topical Anesthetic

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison

Control Center right away.

Section 50567-7

When using this product:

Use only as directed.

Avoid contact with eyes.

Section 50569-3

Stop use and ask a doctor:

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

Section 50570-1

Do not use:

In large quantities, particularly over raw surfaces or blistered areas.

Section 51727-6

Inactive ingredients

Organic Aloe vera oil (Organic Aloe vera powder,

Organic Soybean oil, Vitamin E), Arnica,

Calendula, Caprylic/Capric triglyceride, Carbopol

Ultrez 10, Carrageenan, Chamomille, Organic

Coconut oil, Echinacea, Hypericum, Millefolium,

Phenoxyethanol, Purified water, Organic Safflowe

oil, Organic Shea butter, Sodium hydroxide, Sodium

polyacrylate, Sunflower seed wax

Section 51945-4

Section 53413-1

Questions?

Call Weekdays 10am-6pm Eastern 1.844.MediNatura (1-844-633-4628) or email [email protected]

Section 53414-9

If pregnant or breast-feeding, ask a health

professional before use.

Section 55105-1

Uses

For the temporary relief of pain. Also relieves itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor

skin irritations and rashes due to poison ivy.

Section 55106-9

Active ingredients: Purpose

Lidocaine HCl 4% .........................Topical Anesthetic


Structured Label Content

Indications and Usage (34067-9)
  • For the temporary relief of pain.
  • Also relieves itching associated with minor burns, sunburn, minor cuts, scrapes, inspect bites, minor skin irritations and rashes due to poison ivy.
Dosage and Administration (34068-7)

Directions:

Twist off cap and remove foil seal.

Adults and children 4 years of age and

older: Apply to affected area not more than 3 to

4 times daily.

Children under 4 years of age: do not use,

consult a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison

Control Center right away.

Section 50567-7 (50567-7)

When using this product:

Use only as directed.

Avoid contact with eyes.

Section 50569-3 (50569-3)

Stop use and ask a doctor:

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

Section 50570-1 (50570-1)

Do not use:

In large quantities, particularly over raw surfaces or blistered areas.

Section 51727-6 (51727-6)

Inactive ingredients

Organic Aloe vera oil (Organic Aloe vera powder,

Organic Soybean oil, Vitamin E), Arnica,

Calendula, Caprylic/Capric triglyceride, Carbopol

Ultrez 10, Carrageenan, Chamomille, Organic

Coconut oil, Echinacea, Hypericum, Millefolium,

Phenoxyethanol, Purified water, Organic Safflowe

oil, Organic Shea butter, Sodium hydroxide, Sodium

polyacrylate, Sunflower seed wax

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

Call Weekdays 10am-6pm Eastern 1.844.MediNatura (1-844-633-4628) or email [email protected]

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health

professional before use.

Section 55105-1 (55105-1)

Uses

For the temporary relief of pain. Also relieves itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor

skin irritations and rashes due to poison ivy.

Section 55106-9 (55106-9)

Active ingredients: Purpose

Lidocaine HCl 4% .........................Topical Anesthetic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)