MIRACLE ICE ARTHRITIS PAIN RELIEVER (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]

SPL UNCLASSIFIED SECTION

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, FD&C Blue#1, CI 42090.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 227 g Jar Label

FDN Medical®

MIRACLE
ICE

ARTHRITIS PAIN RELIEVER

ANALGESIC GEL

NET WT. 8 OZ (227 g)

INGREDIENTS AND APPEARANCE

MIRACLE ICE   ARTHRITIS PAIN RELIEVER
menthol and camphor (synthetic) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60691-114
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60691-114-30	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)