CVS HEALTH SUNBURN RELIEF COOLING LIDOCAINE 0.5 PAIN-RELIEVING- lidocaine hcl gel 
CVS Pharmacy

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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CVS Health Sunburn Relief Cooling Gel Lidocaine 0.5% Pain-Relieving Gel

Active ingredients

Lidocaine 0.5% (as Lidocaine HCl)

Purpose

External Analgesic

Uses

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites & minor skin irritations.

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

May stain some fabrics.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Benzophenone-4, Benzyl Alcohol, Blue 1, Carbomer, Isoceteth-20, Phenoxyethanol, Tetrasodium EDTA, Triethanolamine.

Label

CVS38499A

CVS HEALTH SUNBURN RELIEF COOLING LIDOCAINE 0.5 PAIN-RELIEVING 
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SULISOBENZONE (UNII: 1W6L629B4K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOCETETH-20 (UNII: O020065R7Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-022-15170 g in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
2NDC:51316-022-20567 g in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/05/2018
Labeler - CVS Pharmacy (062312574)

Revised: 12/2022
Document Id: f0f196ab-c27e-d23b-e053-2a95a90a23cc
Set id: f0f1969d-10e0-76ee-e053-2995a90a7336
Version: 1
Effective Time: 20221228
 
CVS Pharmacy