Active Ingredients (W/W)
Lidocaine HCl 4%
Solarcaine Burn Pain Relief 4oz Spray
FDA Label NDC 65197-502
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Solarcaine Burn Pain Relief 4oz (NDC 65197-502). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (w/w), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
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
Do Not Use
in large quantities, particularly over raw surfaces or blistered areas
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).
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.
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
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
Package Label. Principal Display Panel
#1 Pharmacist Recommended*
* Pharmacy Times/* U.S News & World
Report 2023-2024
DOT 2Q M5706
L50200A | B6522
CONTAINS NO CFCs WHICH
DEPLETE THE OZONE LAYER
Can Artwork Solarcaine 4% (Solarcaine Burn Pain Relief Spray 4oz 1)
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