3832 Burn Ease

3832 Burn Ease
SPL v3
SPL
SPL Set ID f71eb4f5-2280-5867-e053-6394a90aac57
Route
TOPICAL
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-10

Description

Lidocaine Hydrochloride 2%

Purpose

Analgesic


Medication Information

Purpose

Analgesic

Description

Lidocaine Hydrochloride 2%

Label

Burn Ease

Use(s)

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

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?

1-888-900-2920 8AM-4PM PST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• Store at room temperature

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Proplyene 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

Burn Ease

Use(s)

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

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?

1-888-900-2920 8AM-4PM PST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• Store at room temperature

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Proplyene 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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