Water-jel Unburn

Drug Facts

Composition & Product

Inactive Ingredients

Methylparaben Octoxynol-9 Polysorbate 20 Propylene Glycol Propylparaben Water Spearmint Oil Tea Tree Oil Trolamine .alpha.-tocopherol Acetate Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-03-17

Medication Information

Purpose

External analgesic

Description

Lidocaine HCl 2.5%

Uses

for the temporary relief of pain associated with:

sunburn
minor burns
minor skin irritations
insect bites

Section 53413-1

1-800-275-3433

Monday - Friday (9a.m. - 5 p.m. EST)

www.unburn.info

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: consult a doctor

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Active Ingredient

Lidocaine HCl 2.5%

Other Information

store at 15 ^o to 25 ^oC (59 ^oto 77 ^oF)
do not freeze
you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive Ingredients

acrylates/C20-30 alkyl acrylate crosspolymer, aloe, carbomer, diazolidnyl urea, edetate disodium, glyceryl-7 stearate, methylparaben, octoxynol-9, polysorbate 20, propylene glycol, propylparaben, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate

Principle Display Panel

When Using This Product

avoid contact with eyes

Stop Use and Ask A Doctor If

condition 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

Uses

for the temporary relief of pain associated with:

sunburn
minor burns
minor skin irritations
insect bites

Section 53413-1 (53413-1)

1-800-275-3433

Monday - Friday (9a.m. - 5 p.m. EST)

www.unburn.info

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: consult a doctor

Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Active Ingredient (Active ingredient)

Lidocaine HCl 2.5%

Other Information (Other information)

store at 15 ^o to 25 ^oC (59 ^oto 77 ^oF)
do not freeze
you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive Ingredients (Inactive ingredients)

acrylates/C20-30 alkyl acrylate crosspolymer, aloe, carbomer, diazolidnyl urea, edetate disodium, glyceryl-7 stearate, methylparaben, octoxynol-9, polysorbate 20, propylene glycol, propylparaben, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate

Principle 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)

condition 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

[{"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOXYNOL-9", "unii": "7JPC6Y25QS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SPEARMINT OIL", "unii": "C3M81465G5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "2.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of pain associated with: sunburn minor burns minor skin irritations insect bites", "53413-1": "1-800-275-3433 Monday - Friday (9a.m. - 5 p.m. EST) www.unburn.info", "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: consult a doctor", "Do not use": "in large quantities, particularly over raw surfaces or blistered areas", "Active ingredient": "Lidocaine HCl 2.5%", "Other information": "store at 15 o to 25 o C (59 o to 77 o F) do not freeze you may report a serious adverse reaction to this product to 1-800-275-3433", "Inactive ingredients": "acrylates/C20-30 alkyl acrylate crosspolymer, aloe, carbomer, diazolidnyl urea, edetate disodium, glyceryl-7 stearate, methylparaben, octoxynol-9, polysorbate 20, propylene glycol, propylparaben, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate", "When using this product": "avoid contact with eyes", "Stop use and ask a doctor if": "condition 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information