SOLARCAINE- lidocaine spray

Solarcaine by

Drug Labeling and Warnings

Solarcaine by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine 0.5%

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

Flammable: Do not use while smoking or near heat or flame

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. Do not store at temperatures above 120°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: ask a doctor
• to apply to face, spray in palm of hand and gently apply

Inactive Ingredients

aloe barbadensis leaf juice, isobutane, propane, propylene glycol, glycerin, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, carbomer, diazolidinyl urea, methylparaben, propylparaben, disodium cocoamphodipropionate, disodium EDTA

PRINCIPAL DISPLAY PANEL - 170 g Can Label

#1

Sunburn

Relief

BRAND

PAIN RELIEVING SPRAY

WITH Lidocaine

Solarcaine®

Cools Instantly

Restores Moisture to

Sunburned Skin

Doctor Tested Alcohol Free

cool aloe

burn relief

formula

NET WT 6 OZ (170g)

INGREDIENTS AND APPEARANCE

SOLARCAINE 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0404
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOBUTANE (UNII: BXR49TP611)
PROPANE (UNII: T75W9911L6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	white (Viscous hazy colorless to off-white liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0404-1	127 g in 1 CAN; Type 0: Not a Combination Product	03/01/2016
2	NDC: 11523-0404-2	170 g in 1 CAN; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/06/2012

Labeler - Bayer HealthCare LLC. (112117283)