MEDICATED PAIN RELIEF FOOT CVS- lidocaine 4% spray 
Rite Aid

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 4%................................................................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 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.
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
Stop use and ask 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 • to apply to face, spray into palm of hand and gently apply

Inactive ingredients

Alcohol Denat.
Aloe Barbadensis Leaf Extract
Carbomer
Chamomilla Recutita (Matricaria) Flower Extract
Cucumis Sativus (Cucumber) Fruit Extract
Diazolidinyl Urea
Disodium Cocoamphodipropionate
Disodium EDTA
Glycerin
Propylene Glycol
Simethicone
Tocopheryl Acetate
Triethanolamine
Water

image description

MEDICATED PAIN RELIEF FOOT  CVS
lidocaine 4% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7799
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
CUCUMBER (UNII: YY7C30VXJT)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-7799-4133 mL in 1 CAN; Type 0: Not a Combination Product03/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/08/2018
Labeler - Rite Aid (014578892)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(11822-7799) , label(11822-7799)

Revised: 5/2018
Document Id: 76014676-7866-4dfc-9439-be79fa6a6036
Set id: 0fc56798-4879-4969-bfc3-1ded46f704be
Version: 1
Effective Time: 20180529
 
Rite Aid