Ps-8610

Ps-8610
SPL v3
SPL
SPL Set ID 0e25c936-e40a-e23c-e063-6294a90ac0e4
Route
TOPICAL
Published
Effective Date 2024-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-08
Description

Lidocaine Hydrochloride USP 2%

Purpose

Analgesic

Medication Information

Purpose

Analgesic

Description

Lidocaine Hydrochloride USP 2%

Label

PS-8610

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 Monday-Friday, 8AM-4PM PST

Active Ingredient

Lidocaine Hydrochloride USP 2%

Other Information

• Store at controlled room temperature 20º-25ºC (68º-77ºF)

• 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 Oil, Trolamine

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

PS-8610

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 Monday-Friday, 8AM-4PM PST

Active Ingredient

Lidocaine Hydrochloride USP 2%

Other Information

• Store at controlled room temperature 20º-25ºC (68º-77ºF)

• 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 Oil, Trolamine

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.526311 · Updated: 2026-03-14T23:11:23.873993