The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot Lidocaine Dry (NDC 41167-1740). 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 purposes, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Lidocaine 4%....................................................................................................................................Topical anesthetic
Menthol 1%........................................................................................................................................Topical analgesic
temporarily relieves minor pain
For external use only
■ on large areas of the body or on cut, irritated or swollen skin
■ on puncture wounds
■ for more than one week without consulting a doctor
■ use only as directed. Read and follow all directions and warnings on this label.
■ do not allow contact with the eyes and mucous membranes
■ rare cases of serious burns have been reported with products of this type
■ do not apply to wounds or damaged, broken or irritated skin
■ avoid spraying on face
■ avoid inhalation of spray
■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
■ do not use at the same time as other topical analgesics
■ a transient burning sensation may occur upon application but generally disappears in several days
■ avoid applying into skin folds
■ condition worsens
■ redness is present
■ irritation develops
■ symptoms persist for more than 7 days or clear up and occur again within a few days
■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Extremely Flammable
■ do not use near heat or flame or while smoking
■ avoid long term storage above 104°F (40°C)
■ do not puncture or incinerate. Contents under pressure.
■ do not store at temperatures above 120°F (49°C)
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
adults and children over 12 years:
■ spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
■ product will dry quickly on its own, and does not need to be rubbed in
children 12 years or younger: ask a doctor
alcohol denat. (30%), caprylic/capric triglyceride, isobutane, propylene glycol
MAX STRENGTH LIDOCAINE
NEW
ICY HOT
LIDOCAINE
PLUS MENTHOL
DRY
SPRAY
NET WT 4 OZ (113 g) Pain Relief Spray
Principal Display Panelmax Strength Lidocainenewicy Hotlidocaineplus Mentholdry Spraynet Wt 4 Oz (113 G) Pain Relief Spray (Icy Hot Lidocaine Dry Spray 01)
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