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SPL v1
SPL
SPL Set ID 369c1d16-597c-e1dc-e063-6394a90a3104
Route
TOPICAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Benzalkonium Chloride Polysorbate 20 Caprylyl Glycol Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-05

Description

LIDOCAINE HCI 3% w/w

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

LIDOCAINE HCI 3% w/w

Uses

• For temporarily relief of pain and itching associated with minor • cuts • burns • sunburns • insect bites • scrapes • and minor skin irritations

Warnings

• For external use only.

Ask a doctor if you have • deep puncture wounds • animal bites • serious burns.

When using this product • do not use in or near the eyes • in case of contact, rinse eyes thoroughly with water • do not apply over large areas of the body or in large quantities.

Stop use and ask a doctor if • condition worsens • irritation or rash appears and lasts for more than 72 hours.

Directions

• For adults and Children two years and older: Apply the wipe thoroughly to the affected area. Use up to 3-4 times daily. For best results, allow the area to remain wet for 1-2 minutes.

Active Ingredient

LIDOCAINE HCI 3% w/w

Inactive Ingredients

• Benzalkonium Chloride, Caprylyl Glycol, Phenoxyethanol, Polysorbate 20, Water.

Principal Display Panel

NUMB

FAST-ACTING

PAIN RELIEVING WIPE

LIDOCAINE INFUSED

Wipe Outz

1 X-LARGE WIPE (8 X 7 IN)

DO NOT FLUSH

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.


Structured Label Content

Uses

• For temporarily relief of pain and itching associated with minor • cuts • burns • sunburns • insect bites • scrapes • and minor skin irritations

Purpose

Pain reliever

Warnings

• For external use only.

Ask a doctor if you have • deep puncture wounds • animal bites • serious burns.

When using this product • do not use in or near the eyes • in case of contact, rinse eyes thoroughly with water • do not apply over large areas of the body or in large quantities.

Stop use and ask a doctor if • condition worsens • irritation or rash appears and lasts for more than 72 hours.

Directions

• For adults and Children two years and older: Apply the wipe thoroughly to the affected area. Use up to 3-4 times daily. For best results, allow the area to remain wet for 1-2 minutes.

Active Ingredient

LIDOCAINE HCI 3% w/w

Inactive Ingredients

• Benzalkonium Chloride, Caprylyl Glycol, Phenoxyethanol, Polysorbate 20, Water.

Principal Display Panel

NUMB

FAST-ACTING

PAIN RELIEVING WIPE

LIDOCAINE INFUSED

Wipe Outz

1 X-LARGE WIPE (8 X 7 IN)

DO NOT FLUSH

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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