FDA Label for Ice Cold Analgesic

View Indications, Usage & Precautions

Ice Cold Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Personal Care Products. 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.

Otc - Active Ingredient





Active Ingredients:

Menthol 1%


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 thanĀ  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




Personal Care

Ice cold

analgesic gel

New wt. 8 oz. (227 g)


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