2c0389db-ceb2-422b-9575-bdb8fe649a1e

SPL v2
SPL
SPL Set ID 2c0389db-ceb2-422b-9575-bdb8fe649a1e
Route
topical
Published
Effective Date 2024-06-26
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 80 phenoxyethanol ethylhexylglycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-11-15

Purpose

External Analgesic

Description

Lidocaine HCl 4%


Medication Information

Warnings

For external use only. When using this product

Uses

temporarily relieves pain and itching due to:

  • sunburn
  • minor burns
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
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
Inactive Ingredients

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

Description

Lidocaine HCl 4%

Questions?

1-844-241-5454  

Purpose 

External Analgesic

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Distributed By:

Distributed by:

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

© 2024 WellSpring Pharmaceutical Corporation

MONEY BACK GUARANTEE

Solarcaine is FSA/HSA eligible

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

L50210A | B6526

CONTAINS NO CFCs WHICH

DEPLETE THE OZONE LAYER

Solarcaine After sun pain relief

Structured Label Content

Warnings

For external use only. When using this product

Uses

temporarily relieves pain and itching due to:

  • sunburn
  • minor burns
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
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
Inactive Ingredients (Inactive ingredients)

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

Questions?

1-844-241-5454  

Purpose 

External Analgesic

Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Distributed By: (Distributed by:)

Distributed by:

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

© 2024 WellSpring Pharmaceutical Corporation

MONEY BACK GUARANTEE

Solarcaine is FSA/HSA eligible

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

L50210A | B6526

CONTAINS NO CFCs WHICH

DEPLETE THE OZONE LAYER

Solarcaine After sun pain relief

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)