SPL v4
SPL
SPL Set ID 14f23c28-c713-4868-9f46-66363bf94b2c
Route
TOPICAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Propylene Glycol Aloe Vera Leaf Sodium Hydroxide .alpha.-tocopherol Acetate Polysorbate 81 Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Lidocaine HCl 4%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine HCl 4%

Uses

temporarily relieves pain and itching due to:

  • sunburn
  • minor burns
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
Warnings

For external use only. When using this product

Purpose 

External Analgesic

Directions
  • shake well
  • 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, ask a doctor
  • to apply to face, spray in palm of hand and gently apply
Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Questions?

1-844-241-5454  

Distributed By:

Distributed by:

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

© 2023 WellSpring Pharmaceutical Corporation

MONEY BACK GUARANTEE

Solarcaine is FSA/HSA eligible

Inactive Ingredients

purified water, propylene glycol, aloe barbadensis leaf juice, polysorbate 80, ethylhexylglycerin, tocopheryl acetate (vitamin E acetate), 2-phenoxyethanol, sodium hydroxide

When Using This Product
  • keep out of eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Avoid prolonged storage above 40°C (104°F).
Active Ingredients (w/w)

Lidocaine HCl 4%

Stop Use and Ask A Doctor If
  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days
Keep Out of Reach of Children
  • If swallowed, get medical help or contact a Poison Control Center right away.
Package Label. Principal Display Panel

#1 Pharmacist Recommended*

* Pharmacy Times/* U.S News & World

Report 2023-2024

DOT 2Q M5706

L50200C | B6522

CONTAINS NO CFCs WHICH

DEPLETE THE OZONE LAYER

Solarcaine Burn Pain Relief

Structured Label Content

Uses

temporarily relieves pain and itching due to:

  • sunburn
  • minor burns
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
Warnings

For external use only. When using this product

Purpose 

External Analgesic

Directions
  • shake well
  • 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, ask a doctor
  • to apply to face, spray in palm of hand and gently apply
Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Questions?

1-844-241-5454  

Distributed By: (Distributed by:)

Distributed by:

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

© 2023 WellSpring Pharmaceutical Corporation

MONEY BACK GUARANTEE

Solarcaine is FSA/HSA eligible

Inactive Ingredients (Inactive ingredients)

purified water, propylene glycol, aloe barbadensis leaf juice, polysorbate 80, ethylhexylglycerin, tocopheryl acetate (vitamin E acetate), 2-phenoxyethanol, sodium hydroxide

When Using This Product (When using this product)
  • keep out of eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Avoid prolonged storage above 40°C (104°F).
Active Ingredients (w/w)

Lidocaine HCl 4%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days
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.
Package Label. Principal Display Panel (PACKAGE LABEL. PRINCIPAL DISPLAY PANEL)

#1 Pharmacist Recommended*

* Pharmacy Times/* U.S News & World

Report 2023-2024

DOT 2Q M5706

L50200C | B6522

CONTAINS NO CFCs WHICH

DEPLETE THE OZONE LAYER

Solarcaine Burn Pain Relief

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)