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 Ingredients
Menthol 1%
Camphor 0.5%
Otc - Purpose
Purpose
Topical Analgesic
Indications & Usage
Uses
for the temporary relief of minor aches and pains in muscles and joints associated with:
- simple backache
- strains
- sprains
- sports injuries
- arthritis
- bruises
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 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
Inactive Ingredient
Inactive Ingredients
benzyl alcohol, butylated hydroxy toluene, carbopol, color brilient blue, creasmer RH-40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water, sodium hydroxide.
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
ICE COLD ANALGESIC GEL
Topical Analgesic
NET WT.8 OZ (227g)
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