Burn Spray

Burn Spray
SPL v7
SPL
SPL Set ID c53ab9dd-351a-400b-b873-4f396e0af54d
Route
TOPICAL
Published
Effective Date 2020-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Edetate Disodium Octoxynol 9 Glycerin Hypromellose 2208 (100000 Mpa.s) Trolamine Tea Tree Oil Propylparaben Methylparaben Propylene Glycol Diazolidinyl Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-05-17

Description

Lidocaine HCl 2%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Dosage and Administration
  • 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: consult a doctor

Description

Lidocaine HCl 2%

Uses

for the temporary relief of pain associated with minor burns

Section 50566-9
  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Warnings

For external use only

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Active Ingredient

Lidocaine HCl 2%

Other Information

store at room temperature

you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive Ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, tea tree oil, trolamine, water

Questions Or Comments?



1-800-275-3433 [email protected] www.waterjel.com

Manufactered by Water-Jel Technologies, Inc., 50 Broad Street,

Carlstadt, NJ 07072, USA

Principal Display Panel

When Using This Product

avoid contact with eyes

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

Dosage and Administration (34068-7)
  • 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: consult a doctor

Section 50566-9 (50566-9)
  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Purpose

External analgesic

Warnings

For external use only

Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Active Ingredient (Active ingredient)

Lidocaine HCl 2%

Other Information (Other information)

store at room temperature

you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive Ingredients (Inactive ingredients)

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, tea tree oil, trolamine, water

Questions Or Comments? (Questions or comments?)



1-800-275-3433 [email protected] www.waterjel.com

Manufactered by Water-Jel Technologies, Inc., 50 Broad Street,

Carlstadt, NJ 07072, USA

Principal Display Panel

When Using This Product (When using this product)

avoid contact with eyes

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)