lidocaine hydrochloride 2% gel

lidocaine hydrochloride 2% gel
SPL v3
SPL
SPL Set ID 4977b722-d08d-3d9e-e063-6294a90a9035
Route
topical
Published
Effective Date 2026-01-01
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 acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) carbomer 940

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-01

Purpose

External Analgesic

Description

Lidocaine Hydrochloride 2%


Medication Information

Warnings

For External Use Only

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

■ Children under 2 years of age: Consult a doctor

Other Information

• Store at room temperature

• Tamper Evident. Do not use if seal is torn, cut, or opened.

  • See sachet or cartonfor lot number and expiry date
Inactive Ingredients

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

Description

Lidocaine Hydrochloride 2%

Questions?

Call 1-833-605-84-74 9am-5 pm EST M-F

Label

Use(s)

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

Do Not Use

■ On wounds or damaged skin

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

Active Ingredient

Lidocaine Hydrochloride 2%

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


Structured Label Content

Warnings

For External Use Only

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

■ Children under 2 years of age: Consult a doctor

Other Information

• Store at room temperature

• Tamper Evident. Do not use if seal is torn, cut, or opened.

  • See sachet or cartonfor lot number and expiry date
Inactive Ingredients

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

Questions?

Call 1-833-605-84-74 9am-5 pm EST M-F

Label

Use(s)

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

Do Not Use (Do not use)

■ On wounds or damaged skin

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

Active Ingredient

Lidocaine Hydrochloride 2%

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


Advanced Ingredient Data


Raw Label Data

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