burn jel

burn jel
SPL v5
SPL
SPL Set ID ff621b46-2342-41db-994d-851a09796d08
Route
topical
Published
Effective Date 2020-05-26
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 drug active Since 2010-04-17

Purpose

External analgesic

Description

Lidocaine HCl 2.0 %


Medication Information

Warnings

For external use only

Uses

for the temporary relief of pain associated with minor burns

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
  • spread a thick even layer over affected skin
  • children under 2 years of age: consult a doctor
Other Information
  • store at room temperature
  • you may report a serious adverse reaction to this product to 800-275-3433
Inactive Ingredients

acrylates/C10-30 alkyl acrylate, carbomer, diazolidinyl urea, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, triethanolamine, water

Description

Lidocaine HCl 2.0 %

Principal Display Panel

Do Not Use
  • on large areas of the body
  • on broken, blistered or oozing skin
Active Ingredient

Lidocaine HCl 2.0 %

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

When Using This Product
  • avoid contact with eyes

Stop Use and Ask A Doctor If
  • conditions worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Keep Out of the 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 associated with minor burns

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
  • spread a thick even layer over affected skin
  • children under 2 years of age: consult a doctor
Other Information (Other information)
  • store at room temperature
  • you may report a serious adverse reaction to this product to 800-275-3433
Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate, carbomer, diazolidinyl urea, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, triethanolamine, water

Principal Display Panel

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 %

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

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
  • condition clears up and occurs again within a few days
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

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