Label: ICY HOT KIDS PAIN RELIEF- menthol patch
- NDC Code(s): 62168-0228-1
- 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 ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
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- use only as directed
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- do not bandage tightly
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- avoid contact with eyes and mucous membranes
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- do not expose the area to local heat or to direct sunlight
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- 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
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- avoid applying into skin folds
Stop use and ask a doctor if
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- condition worsens or symptoms persist for more than 7 days
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- symptoms clear up and occur again within a few days
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- redness is present or excessive skin irritation occurs
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- your child experiences severe burning pain, swelling, or blistering where the product was applied
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Directions
children 5 years of age and older:
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- patch may be cut into smaller sizes with scissors prior to removal of the backing
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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
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- once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
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- apply to affected area not more than 3 to 4 times daily
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- wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.
children under 5 years of age: ask a doctor
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Inactive ingredients
aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water
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Principal Display Panel – Pouch Label
ICY HOT®
KIDS
PAIN RELIEF
PATCH
FAST ACTING
EASY TO APPLY AND REMOVE
WEAR UP TO 8 HOURS
WITH NATURALLY-SOURCED
MENTHOL 5%
DEVELOPED WITH PEDIATRICIANS
AGES 5+
CONTAINS 5 PATCHES IN ONE RESEALABLE POUCH
3-1/8" x 4-5/8" (8 cm x 12 cm) EACH
PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2022 www.icyhot.com
Label
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INGREDIENTS AND APPEARANCE
ICY HOT KIDS PAIN RELIEF
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0228 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 205.5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62168-0228-1 270 in 1 CARTON 01/31/2023 1 5 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) 01/31/2023 Labeler - Lead Chemical Co., Ltd. (693727091)