SOLARCAINE COOL ALOE- lidocaine hydrochloride gel 
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Solarcaine ® cool aloe gel

Drug Facts

Active ingredient

Lidocaine hydrochloride 0.5%

Purpose

External analgesic

Uses

temporarily relieves pain and itching due to:

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

Warnings

For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product keep out of eyes

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

  • 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

Inactive Ingredients

aloe barbadensis leaf juice, water, propylene glycol, glycerin, triethanolamine, isopropyl alcohol (0.06% v/v), polysorbate 80, carbomer, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

PRINCIPAL DISPLAY PANEL - 226g Bottle Label

Cools Instantly!

#1

SUNBURN

RELIEF BRAND

Solarcaine ®

cool aloe

BURN RELIEF FORMULA

Pain Relieving Gel with Lidocaine HCl

Restores Moisture

to Sunburned Skin

Doctor Tested

NET WT 8 OZ (226g)

pdp

dfl

SOLARCAINE COOL ALOE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0430
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0430-2226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/201603/17/2021
2NDC:11523-0430-3340 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/201609/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/13/201209/08/2023
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2023
Document Id: eb50322c-4140-3965-e053-2a95a90a8431
Set id: 88f3cb40-2258-4e1c-92fb-e1891ddb3135
Version: 7
Effective Time: 20230908
 
Bayer HealthCare LLC.