Active Ingredients (w/w)

Lidocaine HCl 4%

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:

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243

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

Solarcaine 4%

SOLARCAINE BURN PAIN RELIEF 4OZ
solarcaine burn pain relief 4oz spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65197-502
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 81 (UNII: 2MSF640LWM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65197-502-04	113 g in 1 CAN; Type 0: Not a Combination Product	01/01/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/01/2024

Labeler - WellSpring Pharmaceutical Corporation (110999054)

Solarcaine Burn Pain Relief Spray 4oz