Sunburn Relief Gel

Sunburn Relief Gel
SPL v1
SPL
SPL Set ID 2e7c49de-5438-4858-e063-6294a90ad98c
Route
TOPICAL
Published
Effective Date 2025-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Methylisothiazolinone Water Propylene Glycol Glycerin Aloe Vera Leaf Sodium Hydroxide Isopropyl Alcohol Polysorbate 20 Carbomer Homopolymer, Unspecified Type Benzyl Alcohol Menthol Edetate Disodium Fd&c Blue No. 1 Fd&c Yellow No. 5 Methylchloroisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-19

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

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

Principl Display Panel

sunburn relief gel

Pain Relieving Gel

with Aloe Vera and Lidocaine HCl

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

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

Principl Display Panel (Principl display panel)

sunburn relief gel

Pain Relieving Gel

with Aloe Vera and Lidocaine HCl

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

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