ALOE- lidocaine hcl 0.50% gel 
Kmart Corporation

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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Active ingredient                    Purpose

Lidocaine HCl 0.5%................Pain Reliever

Uses

 Helps relieve the pain associated with sunburn, windburn, insect bites, and minor cuts and scrapes.

Warnings
For external use only.

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


When using this product • avoid contact with eyes. If contact occurs, rinse thoroughly with water.


Stop use and ask a doctor if • condition gets worse • symptoms last more than seven days • symptoms clear up and occur again in a few days

​Keep out of reach of children.​ If product is swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions • Adults and children 2 years and older: apply to affected area not more than 3 - 4 times a day. • Children under 2 years of age: consult a physician

Inactive ingredients Water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Menthol, Polysorbate 20, Tocopheryl Acetate, Quaternium-15, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA, Benzophenone-4, Benzyl Alcohol, Fragrance, FD&C Blue #1, FD&C Yellow #5.

label frontlabel back

ALOE 
lidocaine hcl 0.50% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-263
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
Benzyl Alcohol (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Menthol (UNII: L7T10EIP3A)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Quaternium-15 (UNII: E40U03LEM0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-263-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/201208/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/201208/11/2017
Labeler - Kmart Corporation (008965873)
Registrant - Product Quest (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest927768135manufacture(49738-263) , label(49738-263)

Revised: 8/2017
Document Id: ccaa1b69-2436-4b2d-9086-08ec3fa8106c
Set id: 109a4a3f-d4bb-41c2-a7c6-03ebcbd2f398
Version: 2
Effective Time: 20170811
 
Kmart Corporation