MIRACLE ICE description, usages, side effects, indications, overdosage, supplying and lots more!

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MIRACLE ICE

FDN Enterprises, LLC

MIRACLE ICE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredient Purpose
Menthol 1% Topical analgesic
Camphor 0.5% Topical analgesic

MIRACLE ICE 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

Do not use

  • with other topical pain relievers
  • with heating pads or heating devices

When using this product

  • do not use in or near the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

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

If pregnant or breast-feeding, ask a health professional before use.

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

MIRACLE ICE 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, CI 42090.

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

PRINCIPAL DISPLAY PANEL - 277 g Jar Label

FDN Medical ®

MIRACLE
ICE

ANALGESIC GEL

NET WT. 8 OZ (277 g)

MIRACLE ICE

MIRACLE ICE

Menthol and Camphor (synthetic) GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:60691-115
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 1 g
CAMPHOR (SYNTHETIC) 0.5 g

Inactive Ingredients

Ingredient Name Strength
water
propylene glycol
methyl salicylate
SODIUM HYDROXIDE
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60691-115-30 227 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-07-15


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Be sure to consult your doctor before taking any medication!
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