Fsk-5

Fsk-5
SPL v5
SPL
SPL Set ID 4c62196a-9f94-4823-b95f-447f012f10bf
Route
TOPICAL
Published
Effective Date 2014-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Carbomer Homopolymer Type C Glycerin Propylene Glycol Methylparaben Tea Tree Oil Diazolidinyl Urea Trolamine Octoxynol-9 Carbomer Homopolymer Type B Propylparaben Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-11
Description

Lidocaine HCl 2.0 %

Purpose

External analgesic

Medication Information

Purpose

External analgesic

Description

Lidocaine HCl 2.0 %

Uses

for the temporary relief of pain associated with minor burns

Section 42229-5
MEDICAL DEVICES 
 2  2" x 6" Burn Dressings
 2  4" x 4" Burn Dressings
 1 12" x 16" Face Mask
 1  2" x 2.2 yd Elastic Bandage

 

Warnings

For external use only

Questions

1-800-275-3433 www.waterjel.com

Directions
  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • spread a thick even layer over affected skin
  • children under 2 years of age: consult a doctor
Do Not Use

on large areas of the body

on broken, blistered or oozing skin

Active Ingredient

Lidocaine HCl 2.0 %

Other Information
  • store at room temperature
  • do not use packeet if opened or torn
  • you may report a serious adverse reaction to this product to 800-275-3433
Inactive Ingredients

triethanolamine, meleleuca alternifolia (tea tree) leaf oil, glycerin, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, carbomer, octoxynol-9, acrylates C/10-30 alkyl acrylate, disodium EDTA

Principal Display Panel

When Using This Product
  • avoid contact with eyes

Stop Use and Ask A Doctor If
  • conditions worsens
  • symptoms persist for more than 7 days
  • symptoms clears up and occur again in a few days
Principal Display Panel Packet

Keep Out of the 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 associated with minor burns

Section 42229-5 (42229-5)
MEDICAL DEVICES 
 2  2" x 6" Burn Dressings
 2  4" x 4" Burn Dressings
 1 12" x 16" Face Mask
 1  2" x 2.2 yd Elastic Bandage

 

Purpose

External analgesic

Warnings

For external use only

Questions

1-800-275-3433 www.waterjel.com

Directions
  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • spread a thick even layer over affected skin
  • children under 2 years of age: consult a doctor
Do Not Use (Do not use)

on large areas of the body

on broken, blistered or oozing skin

Active Ingredient (Active ingredient)

Lidocaine HCl 2.0 %

Other Information (Other information)
  • store at room temperature
  • do not use packeet if opened or torn
  • you may report a serious adverse reaction to this product to 800-275-3433
Inactive Ingredients (Inactive ingredients)

triethanolamine, meleleuca alternifolia (tea tree) leaf oil, glycerin, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, carbomer, octoxynol-9, acrylates C/10-30 alkyl acrylate, disodium EDTA

Principal Display Panel

When Using This Product (When using this product)
  • avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions worsens
  • symptoms persist for more than 7 days
  • symptoms clears up and occur again in a few days
Principal Display Panel Packet

Keep Out of the Reach of Children (Keep out of the 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: 2026-02-15T11:56:27.297062 · Updated: 2026-03-14T22:54:56.160161