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Sunburn Relief Gel

CVS 005.003/005AE Sunburn Relief Gel

Approved
Approval ID

d7f52394-5cc1-48a6-ae89-9fc63b515758

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

CVS

DUNS: 062312574

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69842-909
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine HCl
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (15)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 g
Code: V13007Z41A
Classification: ACTIR

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Principal display panel

CVS Health ®

NDC 69842-909-34

Burn Relief Gel

LIDOCAINE HCl 0.5%

Pain Relieving Gel

Moisturizing Gel

  • Cools & soothes sunburned skin
  • Paraben & phthalate free

Aloe Vera

NET WT 8 OZ (226 g)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Uses

for the temporary relief of pain and itching associated with

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/1/2025

ADVERSE REACTION

Distributed By: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2024 CVS/pharmacy

V-16346

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredient

Lidocaine HCl 0.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

External analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/1/2025

Do not use

in large quantities, particularly over raw surfaces or blistered areas

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/1/2025

When using this product

avoid contact with the eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clean up and occur again within a few days

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive ingredients

water, propylene glycol, glycerin, Aloe Barbadensis Leaf Juice, sodium hydroxide, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5

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Sunburn Relief Gel - FDA Drug Approval Details