MIRACLE ICE ULTRA STRENGTH (menthol and camphor- synthetic gel

Miracle Ice by

Drug Labeling and Warnings

Miracle Ice by is a Otc medication manufactured, distributed, or labeled by FDN Enterprises,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
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

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

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 14720, CI 16185, CI 42090

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

PRINCIPAL DISPLAY PANEL - 227 g Jar Label

FDN Medical®
MIRACLE
ICE

ULTRA STRENGTH

ANALGESIC GEL

NET WT. 8 OZ (227 g)

INGREDIENTS AND APPEARANCE

MIRACLE ICE   ULTRA STRENGTH
menthol and camphor (synthetic) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60691-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	1 g  in 100 g
Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET)	Camphor (synthetic)	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Methyl Salicylate (UNII: LAV5U5022Y)
Sodium Hydroxide (UNII: 55X04QC32I)
Methylparaben Sodium (UNII: CR6K9C2NHK)
Propylparaben Sodium (UNII: 625NNB0G9N)
Carmoisine (UNII: DR4641L47F)
Amaranth (UNII: 37RBV3X49K)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60691-116-30	227 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	07/15/2013

Labeler - FDN Enterprises,LLC (965743867)