TOPCARE EVERYDAY AFTER SUN COOLING- lidocaine hydrochloride gel 
TOPCO ASSOCIATES 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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TopCare Everyday After Sun Cooling Gel

Active Ingredient

Lidocaine hydrochloride 0.5%

Purpose

External Analgesic

Uses

temporarily relieves pain and itching due to:

Warnings

​Do not use

​in large quantities, particularly over raw surfaces or blistered areas.

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

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

Label

TopCare Everyday After Sun Cooling Gel

8 OZ (226 g)

NDC 36800-953-80

TOP45898E1F1

TOPCARE EVERYDAY AFTER SUN COOLING 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-953
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
MENTHOL (UNII: L7T10EIP3A)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-953-80226 g in 1 BOTTLE; Type 0: Not a Combination Product12/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/05/2018
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 2/2021
Document Id: baff690e-937e-cf8c-e053-2995a90af7cd
Set id: baff7293-e1a3-d1f2-e053-2995a90a93ca
Version: 1
Effective Time: 20210210
 
TOPCO ASSOCIATES LLC