Otc - Active Ingredient
Active Ingredients:
Menthol 1%
Ice Cold Analgesic
FDA Label NDC 29500-9034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Personal Care Products for the product Ice Cold Analgesic (NDC 29500-9034). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical analgesic
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.
Indications & Usage
Uses for the temporary relief of minor aches and pains in muscles and joints associated with:
simple backache
sports injuries
strains
arthritis
sprains
bruises
Warnings
Warnings
For external use only
Do not use with other topical pain relievers, with heating pads or heating devices
When using this product do not use in or near eyes, do not apply to wounds or damaged skin
do not bandage tightly
Stop use and ask doctor if condition worsens, symptoms last more than days or clear up and occur again within a few days, redness or irritation develops
If pregnant or breast feeding ask a health professional before use.
For external use only
Do not use with other topical pain relievers, with heating pads or heating devices
When using this product do not use in or near eyes, do not apply to wounds or damaged skin
do not bandage tightly
Stop use and ask doctor if condition worsens, symptoms last more than days or clear up and occur again within a few days, redness or irritation develops
If pregnant or breast feeding ask a health professional before use.
Dosage & Administration
Directions
Clean affected area before applying product
adults and children 2 years of age and older; apply to affected area not more than 3-4 times daily
Inactive Ingredient
Inactive ingredients carbomer, isopropyl alcohol, kathon CG, sodium hydroxide, thymol, water (aqua), FD and C blue no.1
Package Label.Principal Display Panel
Label (Icegel)
Personal Care
Ice cold
analgesic gel
New wt. 8 oz. (227 g)
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