Label: ICY HOT LIDOCAINE DRY- lidocaine, menthol spray
- NDC Code(s): 41167-1740-2
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Use
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Warnings
For external use only
Do not use
■ 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
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 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
Stop use and ask a doctor if
■ 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)
- Directions
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ICY HOT LIDOCAINE DRY
lidocaine, menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-1740 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 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOBUTANE (UNII: BXR49TP611) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-1740-2 113 mL in 1 CAN; Type 0: Not a Combination Product 06/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 06/01/2019 Labeler - Chattem, Inc. (003336013)