SUNBURN PAIN RELIEVER CVS- lidocaine hydrochloride 0.5% gel 
CVS

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%                         Pain Reliever

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 RELIEVER  CVS
lidocaine hydrochloride 0.5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-840
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 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Alcohol (UNII: ND2M416302)  
Menthol (UNII: L7T10EIP3A)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylene Glycol (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-840-06226 g in 1 BOTTLE; Type 0: Not a Combination Product01/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/18/2017
Labeler - CVS (062312574)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(69842-840) , label(69842-840)

Revised: 11/2017
Document Id: 149bfd2d-6d8a-4c40-a919-186997efe216
Set id: bb5b37f1-b273-4732-852c-b7fd44db1ce2
Version: 2
Effective Time: 20171130
 
CVS