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 North & South Wholesalers Llc. 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 Ingredient
Menthol 1.25%
Otc - Purpose
Purpose
Topical Analgesic
Indications & Usage
Uses
- temporarily relieves minor aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- strains
- bruises
- sports injuries
- sprains
- provides cooling penetrating relife
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- with other topical pain relievers
- with heating pads or heating devices
Otc - When Using
When using this product
- do not use in or near the eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clean up and occur again within a few days
- redness or irritation develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children
If swallowed, get medical help or contact a Poison Control Center right away
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 to 4 times daily
- children under 2 years of age: ask a doctor
Other
Other information
- store at controlled room temperature 20 to 25°C (68 to 77°F) in a tightly closed container.
- do not use, pour, spill or store near heat or open flame.
Inactive Ingredient
Inactive Ingredients
benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water.
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
ICE COLD ANALGESIC GEL
Topical Analgesic
NET WT.8 OZ (227g)
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