Cvs 005.003/005ae

Cvs 005.003/005ae
SPL v14
SPL
SPL Set ID d7f52394-5cc1-48a6-ae89-9fc63b515758
Route
TOPICAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Propylene Glycol Glycerin Aloe Vera Leaf Sodium Hydroxide Isopropyl Alcohol Polysorbate 80 Carbomer Homopolymer, Unspecified Type Phenoxyethanol Benzyl Alcohol Menthol Edetate Disodium Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-31
Description

Lidocaine HCl 0.5%

Purpose

External analgesic

Medication Information

Purpose

External analgesic

Description

Lidocaine HCl 0.5%

Uses

for the temporary relief of pain and itching associated with

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

For external use only

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
Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Adverse Reaction

Distributed By: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2024 CVS/pharmacy

V-16346

Active Ingredient

Lidocaine HCl 0.5%

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

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)

When Using This Product

avoid contact with the eyes

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

Keep Out of Reach of Children.

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

Structured Label Content

Uses

for the temporary relief of pain and itching associated with

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

External analgesic

Warnings

For external use only

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
Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Adverse Reaction (ADVERSE REACTION)

Distributed By: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2024 CVS/pharmacy

V-16346

Active Ingredient (Active ingredient)

Lidocaine HCl 0.5%

Inactive Ingredients (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

Principal Display Panel (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)

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:29.792515 · Updated: 2026-03-14T23:12:45.219834