FDA Label for Icy Hot Kids Pain Relief
View Indications, Usage & Precautions
Icy Hot Kids Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Lead Chemical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 5%
Purpose
Topical analgesic
Uses
temporarily relieves minor aches and pains of muscles and joints associated with:
▪ arthritis▪ simple backache▪ strains▪ sprains▪ bruises
Warnings
For external use only
Do Not Use
▪ on wounds or on irritated or damaged skin▪ with a heating pad
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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
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
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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