ICEQUAKE LIDOCAINE ANALGESIC- lidocaine hydrochloride liquid

IceQuake Lidocaine Analgesic by

Drug Labeling and Warnings

IceQuake Lidocaine Analgesic by is a Otc medication manufactured, distributed, or labeled by Dextrum Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Lidocaine HCI 4%

PURPOSE

PURPOSE

Topical Anesthetic

DO NOT USE

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

STOP USE

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

WARNINGS

Warnings

For external use only

INDICATIONS & 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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets.

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

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & 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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ICEQUAKE LIDOCAINE ANALGESIC 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-026-03	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/01/2022

Labeler - Dextrum Laboratories, Inc (007392322)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories, Inc		007392322	manufacture(65852-026)