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Sunburn Pain Reliever CVS

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 0.5g in 100g
Labeler: CVS
NDC Code: 69842-840

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.

Drug Facts

Active ingredient                                             Purpose

Lidocaine Hydrochloride 0.5%                         Pain Reliever

Uses for temporary relief of pain and itching due to
  • sunburn
  • minor burns
  • insect bites
  • cuts
  • scrapes

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

SUNBURN PAIN RELIEVER  CVS
lidocaine hydrochloride 0.5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-840
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CARBOXYPOLYMETHYLENE 
Diazolidinyl Urea 
EDETATE DISODIUM ANHYDROUS 
Glycerin 
Isopropyl Alcohol 
Menthol 
Polysorbate 80 
Propylene Glycol 
TROLAMINE 
Water 
Packaging
#Item CodePackage Description
1NDC:69842-840-06226 g in 1 BOTTLE
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/FEIOperations
Product Quest Mfg927768135manufacture(69842-840), label(69842-840)

Revised: 11/2017
 
CVS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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