Icequake Lidocaine Analgesic

Icequake Lidocaine Analgesic
SPL v1
SPL
SPL Set ID 441daa6f-f273-ac09-e063-6394a90a252c
Route
TOPICAL
Published
Effective Date 2022-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Edetate Disodium Isopropyl Alcohol Glycerin Water Xanthan Gum Polysorbate 20 Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-01

Description

ACTIVE INGREDIENTS: Lidocaine HCI 4%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Indication & usage section

Use Temporarily relieves minor pain

• adults and children over 12 years:

apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

  • children 12 years or younger: ask a doctor

Dosage and Administration

DOSAGE AND ADMINISTRATION:

• adults and children over 12 years:

apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

  • children 12 years or younger: ask a doctor

Description

ACTIVE INGREDIENTS: Lidocaine HCI 4%

Section 50565-1

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if condition worsens

  • symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50570-1

Do not use

  • on large areas of the body or on cut, irritated or swollen skin a on puncture wounds
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to area of use

Section 51727-6

Inactive ingredients

Disodium EDTA, isopropyl alcohol, glycerin, methylparaben, polysorbate 20, propylparaben, purified water, xanthan gum.

Section 51945-4

ICE

QUAKE

Maximum Strength

4%. peel back here

Lidocaine

Topical Analgesic Liquid

2.5 fl.oz. (74 ml)

IceQuake®

Roll On Applicator

  • Fast Acting
  • Numbing
  • No Irritation
  • Unscented

NDC# 69822-430-03

DRUG FACTS

ACTIVE INGREDIENTS: PURPOSE

Lidocaine HCI 4%....... Topical Anesthetic

DRUG FACTS CONTINUED LIFT LABEL AT TOP RIGHT

Section 53414-9

iF pregnant or breast-feeding ask a health professional before use.

Section 55105-1

PURPOSE

Topical Anesthetic

Section 55106-9

ACTIVE INGREDIENTS:

Lidocaine HCI 4%


Structured Label Content

Indications and Usage (34067-9)

Indication & usage section

Use Temporarily relieves minor pain

• adults and children over 12 years:

apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

  • children 12 years or younger: ask a doctor

Dosage and Administration (34068-7)

DOSAGE AND ADMINISTRATION:

• adults and children over 12 years:

apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

  • children 12 years or younger: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens

  • symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50570-1 (50570-1)

Do not use

  • on large areas of the body or on cut, irritated or swollen skin a on puncture wounds
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to area of use

Section 51727-6 (51727-6)

Inactive ingredients

Disodium EDTA, isopropyl alcohol, glycerin, methylparaben, polysorbate 20, propylparaben, purified water, xanthan gum.

Section 51945-4 (51945-4)

ICE

QUAKE

Maximum Strength

4%. peel back here

Lidocaine

Topical Analgesic Liquid

2.5 fl.oz. (74 ml)

IceQuake®

Roll On Applicator

  • Fast Acting
  • Numbing
  • No Irritation
  • Unscented

NDC# 69822-430-03

DRUG FACTS

ACTIVE INGREDIENTS: PURPOSE

Lidocaine HCI 4%....... Topical Anesthetic

DRUG FACTS CONTINUED LIFT LABEL AT TOP RIGHT

Section 53414-9 (53414-9)

iF pregnant or breast-feeding ask a health professional before use.

Section 55105-1 (55105-1)

PURPOSE

Topical Anesthetic

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Lidocaine HCI 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)