Publix 005.003/005ae

Publix 005.003/005ae
SPL v17
SPL
SPL Set ID 9660f5e1-d39e-4f86-bf96-dff0f3bb729d
Route
TOPICAL
Published
Effective Date 2025-06-17
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 2017-01-10

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 PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

1-888-267-3037 publix.com

SCAN HERE FOR MORE INFORMATION

PUBLIX

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

When Using This Product

avoid contact with the eyes

Principal Display Panel

Burn Relief

AFTER-SUN 

PAIN-RELIEVING

GEL WITH ALOE

WITH LIDOCAINE HCl.

SUNBURN RELIEF.

P

NET WT 8 OZ (226 g)

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear 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 (purpose)

External analgesic

Warnings (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 PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

1-888-267-3037 publix.com

SCAN HERE FOR MORE INFORMATION

PUBLIX

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

When Using This Product (When using this product)

avoid contact with the eyes

Principal Display Panel (principal display panel)

Burn Relief

AFTER-SUN 

PAIN-RELIEVING

GEL WITH ALOE

WITH LIDOCAINE HCl.

SUNBURN RELIEF.

P

NET WT 8 OZ (226 g)

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 clear 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)