MIRACLE ICE  THERAPEUTIC- menthol and camphor (synthetic) gel 
FDN Enterprises, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Miracle Ice
Therapeutic

Drug Facts

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

Uses

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

Other information

Inactive ingredients

Aqua, Propylene Glycol, Carbomer, Methyl Salicylate, Sodium Hydroxide, Sodium Methyl Paraben, Sodium Propyle Paraben, CI 42090, CI 19140

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

PRINCIPAL DISPLAY PANEL - 227 g Jar Label

FDN Medical®
MIRACLE
ICE

THERAPEUTIC

ANALGESIC GEL

NET WT. 8 OZ (227 g)

Principal Display Panel - 227 g Jar Label
MIRACLE ICE   THERAPEUTIC
menthol and camphor (synthetic) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1 g  in 100 g
Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET) Camphor (synthetic)0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60691-117-30227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34807/15/2013
Labeler - FDN Enterprises, LLC (965743867)

Revised: 9/2013
Document Id: 9f93e6b6-0a51-4039-b217-daae7b62e9f9
Set id: 293e4559-7b10-467a-9926-f59905fbc568
Version: 1
Effective Time: 20130920
 
FDN Enterprises, LLC