SPL v1
SPL
SPL Set ID 990c6abb-413a-4e75-a2b5-a954d53c1904
Route
TOPICAL
Published
Effective Date 2025-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Arnica Montana Flower C13-14 Isoparaffin Elosulfase Alfa Dimethyl Sulfone Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Isopropyl Palmitate Laureth-7 Phenoxyethanol Polyacrylamide (crosslinked; 2 Mole Percent Bisacrylamide) Propylene Glycol Stearic Acid Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-27

Description

Lidocaine HCL 4%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine HCL 4%

Uses

For the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations

Section 42229-5

Questions? 866-488-0066

Warnings
  • For external use only.
  • Avoid contact with eyes

Stop use and ask a doctor if

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor.

Do not use

  • On wounds or damaged skin.
Direction

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician.

Product Label

AlphaMale DELAY LABEL

AlphaMal DELAY BOX

Active Ingredient

Lidocaine HCL 4%

Other Information

Do not use if seal is broken.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract,C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil,

Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid,Tea Tree Oil, Triethanolamine.

Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations

Section 42229-5 (42229-5)

Questions? 866-488-0066

Purpose

External Analgesic

Warnings
  • For external use only.
  • Avoid contact with eyes

Stop use and ask a doctor if

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor.

Do not use

  • On wounds or damaged skin.
Direction

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician.

Product Label (Product label)

AlphaMale DELAY LABEL

AlphaMal DELAY BOX

Active Ingredient

Lidocaine HCL 4%

Other Information (Other information)

Do not use if seal is broken.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract,C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil,

Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid,Tea Tree Oil, Triethanolamine.

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

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)