basics 005.003/005ae

basics 005.003/005ae
SPL v18
SPL
SPL Set ID adb638ec-4a7c-42f2-b249-0ac53a8dd4b2
Route
topical
Published
Effective Date 2025-06-27
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

Purpose

External analgesic

Description

Lidocaine HCl 0.5%


Medication Information

Warnings

For external use only

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

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
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

Description

Lidocaine HCl 0.5%

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Adverse Reaction

"Alexa, reorder Amazon Basics Sunburn Relief Gel." alexa

Distributed by: Amazon.com Services LLC

Seattle, WA 98109   1-877-485-0385

©2024 Amazon.com Services, LLC. or its affiliates

www.amazon.com/amazonbasics

Active Ingredient

Lidocaine HCl 0.5%

Principl Display Panel

amazon basics

sunburn relief gel

Pain Relieving Gel

with Aloe Vera and Lidocaine HCl

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 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

Warnings

For external use only

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

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
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

Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Adverse Reaction (Adverse reaction)

"Alexa, reorder Amazon Basics Sunburn Relief Gel." alexa

Distributed by: Amazon.com Services LLC

Seattle, WA 98109   1-877-485-0385

©2024 Amazon.com Services, LLC. or its affiliates

www.amazon.com/amazonbasics

Active Ingredient (Active ingredient)

Lidocaine HCl 0.5%

Principl Display Panel (Principl display panel)

amazon basics

sunburn relief gel

Pain Relieving Gel

with Aloe Vera and Lidocaine HCl

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 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

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