PAIN RELIEF ROLL-ON RITE AID- lidocaine hcl gel 
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 HCl 4%..............................................Topical anesthetic

Uses For temporary relief of pain and itching

Warnings
For external use only.
When using this product • use only as directed • avoid contact with eyes • do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

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: consult a doctor.

Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis
Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl
Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol,
Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium
EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, SD
Alcohol 40, Steareth-21, Water.

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PAIN RELIEF ROLL-ON  RITE AID
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Ceteth-20 Phosphate (UNII: 921FTA1500)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
Dimethicone (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Methylparaben (UNII: A2I8C7HI9T)  
ALCOHOL (UNII: 3K9958V90M)  
Steareth-21 (UNII: 53J3F32P58)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1116-374 mL in 1 CONTAINER; Type 0: Not a Combination Product09/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/29/2017
Labeler - Rite Aid (014578892)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(11822-1116) , label(11822-1116)

Revised: 5/2018
Document Id: f9317ead-5069-4f69-b5c9-310771f518d1
Set id: 0a16128f-a329-44a8-9cb9-294d890e3e90
Version: 1
Effective Time: 20180524
 
Rite Aid