FDA Label for Miracle Ice Arthritis Pain Reliever

View Indications, Usage & Precautions

Miracle Ice Arthritis Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Fdn Enterprises, 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.

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Drug Facts

Distributed by:
FDN Enterprises, LLC.
Opa Locka, FL 33054


Otc - Purpose



Active IngredientPurpose
Menthol 1%Topical analgesic
Camphor 0.5%Topical analgesic

Uses



  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • arthritis
    • simple backache
    • strains
    • bruises
    • sport injuries
    • sprains

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 clear 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


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 Information



  • Store at room temperature 59°-86°F (15°-30°C).
  • Keep jar tightly closed and away from open heat or flame

Inactive Ingredients



Aqua, Propylene Glycol, Carbomer, Methyl Salicylate, Sodium Hydroxide, Sodium Methyl Paraben, Sodium Propyle Paraben, FD&C Blue#1, CI 42090.


Principal Display Panel - 227 G Jar Label



FDN Medical®

MIRACLE
ICE

ARTHRITIS PAIN RELIEVER

ANALGESIC GEL

NET WT. 8 OZ (227 g)


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