Otc - Active Ingredient
ACTIVE INGREDIENTS:
Lidocaine HCI 4%
The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories, Inc for the product Icequake Lidocaine Analgesic (NDC 65852-026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - do not use, otc - stop use, warnings, indications & usage, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS:
Lidocaine HCI 4%
Do not use
When using this product
Stop use and ask a doctor if condition worsens
iF pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Inactive ingredients
Disodium EDTA, isopropyl alcohol, glycerin, methylparaben, polysorbate 20, propylparaben, purified water, xanthan gum.
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
ICE
QUAKE
Maximum Strength
4%. peel back here
Lidocaine
Topical Analgesic Liquid
2.5 fl.oz. (74 ml)
IceQuake®
Roll On Applicator
NDC# 69822-430-03
DRUG FACTS
ACTIVE INGREDIENTS: PURPOSE
Lidocaine HCI 4%....... Topical Anesthetic
DRUG FACTS CONTINUED LIFT LABEL AT TOP RIGHT
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