1290 Xeroburn Burn Gel 67777-129-00

1290 Xeroburn Burn Gel 67777-129-00
SPL v7
SPL
SPL Set ID 58985046-ca9c-12be-e053-2991aa0abe72
Route
TOPICAL
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Trolamine Methylparaben Glycerin Imidurea Propylene Glycol Propylparaben Water Tea Tree Oil Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-07

Description

Lidocaine Hydrochloride 2%

Purpose

Analgesic


Medication Information

Purpose

Analgesic

Description

Lidocaine Hydrochloride 2%

Label

XeroBurn Burn Gel

Use(s)

■ For the temporary relief of pain associated with ■ Minor burns ■ Sunburn

■ Provides cooling pain relief

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

■ On wounds or damaged skin

■ In large quantities, particularly over raw surfaces or blistered areas

Questions?

1-888-396-2739 Monday - Friday, 9AM - 5PM EST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosscopolymer, Carbomer, Glycerin, Imidazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine

When Using This Product

■ Avoid contact with the eyes

■ Do not bandage tightly

Stop Use and Ask A Doctor If

■ Condition worsens

■ Symptoms persist for more than 7 days

■ Symptoms 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 (1-800-222-1222) right away.


Structured Label Content

Label

XeroBurn Burn Gel

Use(s)

■ For the temporary relief of pain associated with ■ Minor burns ■ Sunburn

■ Provides cooling pain relief

Purpose

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)

■ On wounds or damaged skin

■ In large quantities, particularly over raw surfaces or blistered areas

Questions?

1-888-396-2739 Monday - Friday, 9AM - 5PM EST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosscopolymer, Carbomer, Glycerin, Imidazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine

When Using This Product (When using this product)

■ Avoid contact with the eyes

■ Do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ Condition worsens

■ Symptoms persist for more than 7 days

■ Symptoms 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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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