Label: ICY HOT KIDS PAIN RELIEF- menthol patch
- NDC Code(s): 41167-0099-0
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 23, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
■ use only as directed
■ do not bandage tightly
■ avoid contact with eyes and mucous membranes
■ do not expose the area to local heat or to direct sunlight
■ rare cases of serious burns have been reported with products of this type
■ 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 or symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ redness is present or excessive skin irritation occurs
■ 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:
■ patch may be cut into smaller sizes with scissors prior to removal of the backing
■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
■ 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
■ apply to affected area not more than 3 to 4 times daily
■ 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
PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION
Keep carton as it contains important information.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ICY HOT KIDS PAIN RELIEF
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0099 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) NONOXYNOL-30 (UNII: JJX07DG188) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) METHYL ACRYLATE (UNII: WC487PR91H) ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) ACRYLIC ACID (UNII: J94PBK7X8S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0099-0 5 in 1 CARTON; Type 0: Not a Combination Product 01/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/15/2023 Labeler - Chattem, Inc. (003336013)
