SUNBURN PAIN RELIEF- lidocaine hydrochloride 0.5% gel 
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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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Drug Facts

Active ingredient                                             Purpose

Lidocaine Hydrochloride 0.5%                        External analgesic

Uses for temporary relief of pain and itching due to

Warnings

For external use only

When using this product

  • avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask a doctor if

• symptoms last more than 7 days.

Keep out of reach of the children

Directions

• adults and children 2 years of age and older: apply to affected area, not more than 3 to 4 times a day
• children under 2 years of age: consult a physician

Inactive ingredients

Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80,
Propylene Glycol, Triethanolamine, Water, Yellow 5

image description

SUNBURN PAIN RELIEF 
lidocaine hydrochloride 0.5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-883
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 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Alcohol (UNII: ND2M416302)  
Menthol (UNII: L7T10EIP3A)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylene Glycol (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-883-061 in 1 CARTON02/12/2016
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/12/2016
Labeler - Top Care (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-883) , label(36800-883)

Revised: 6/2018
Document Id: 3b45baff-4756-4895-b9df-486b605665a0
Set id: caf83b63-604e-43ae-85a0-b31db5fd2388
Version: 1
Effective Time: 20180626
 
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