Label: ICY HOT- lidocaine, menthol patch
- NDC Code(s): 62168-1720-2
- Packager: Lead Chemical Co. Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 2, 2024
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- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Use
- Warnings
- Do not use
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When using this product
- •
- use only as directed
- •
- do not bandage tightly
- •
- avoid contact with the eyes and mucous membranes
- •
- rare cases of serious burns have been reported with products of this type
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- a transient burning sensation may occur upon application but generally disappears in several days
- •
- dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children and pets.
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Directions
adults and children 12 years of age and older:
- •
- clean and dry affected area
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- remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
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- carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
- •
- once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
- •
- use 1 patch at a time and not more than 3 to 4 times daily
children under 12 years of age: consult a doctor
- Inactive ingredients
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Package/Label Principal Display Panel
LIDOCAINE 4% + MENTHOL 1%
ICY HOT®
MAX
Pain Relief Patch
LIDOCAINE
PATCH- •
- Maximum Strength Lidocaine
Without a Prescription* - •
- Penetrates for Fast, Targeted Relief
- •
- Comfortable Fabric
- •
- Stays in Place
*Among OTC Topical Analgesics
Contains 1 Patch
3-15/16” x 5-1/2” (10 cm x 14 cm)CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020
www.icyhot.com Made in Japan.Label
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INGREDIENTS AND APPEARANCE
ICY HOT
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-1720 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 240 mg MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 60 mg Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) NONOXYNOL-30 (UNII: JJX07DG188) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62168-1720-2 400 in 1 CARTON 05/10/2021 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 01/15/2017 Labeler - Lead Chemical Co. Ltd. (693727091)