MEDIC ICE  - menthol gel 
Straight Arrow Products, Inc.

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.

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Active Ingredient

Menthol 7%

Purpose

Pain relieving gel

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

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.



Do not use

  •  on wounds or damaged skin
  • with heating pads or heating devices
  •  with other ointments, creams, sprays or liniments
  •  with tight bandages

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if:

  • a rash appears
  • condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days

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


Directions

Inactive Ingredients   Water, Alcohol, Laureth-4, Carbomer, Triethanolamine, Aloe Vera, Benzocaine, Thymol, Camphor, Methylsulfonylmethane (MSM), Glucosamine HCl, Chondroitin Sulfate, Oil Complex - (Oregano, Eucalyptus, Sage, Patchouli, Lavender, Rosemary, Ginger, Peppermint), Fragrance, Mineral Complex - (Magnesium Sulfate, Copper Sulfate, Calcium Sulfate, Calcium Carbonate, Lithium Chloride, Potassium Chloride, Sodium Sesquicarbonate, Ammonium Chloride), Herbal Complex - (Arnica, Slippery Elm, Chickweed, Comfrey, Myrrh, Hops, Marshmallow, Plantain, Green Tea), FD and C Blue No. 1.

ID:                        Med1
Descriptive Text:   Medic Ice label
File Name:            medicice.jpg

Medic Ice Label


MEDIC ICE  
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62001-0318
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
BENZOCAINE (UNII: U3RSY48JW5)  
LAURETH-4 (UNII: 6HQ855798J)  
THYMOL (UNII: 3J50XA376E)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALOE (UNII: V5VD430YW9)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
PATCHOULI OIL (UNII: F3IN55X5PO)  
GINGER OIL (UNII: SAS9Z1SVUK)  
SAGE OIL (UNII: U27K0H1H2O)  
OREGANO (UNII: 0E5AT8T16U)  
GLUCOSAMINE (UNII: N08U5BOQ1K)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
LITHIUM CHLORIDE (UNII: G4962QA067)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV)  
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ELM (UNII: 63POE2M46Y)  
STELLARIA MEDIA (UNII: 2H03479QVR)  
COMFREY (UNII: D05HXK6R3G)  
MYRRH (UNII: JC71GJ1F3L)  
HOPS (UNII: 01G73H6H83)  
PLANTAGO MAJOR (UNII: W2469WNO6U)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62001-0318-1318880.8 g in 1 CONTAINER
2NDC:62001-0318-2454 g in 1 CONTAINER
3NDC:62001-0318-371 g in 1 TUBE, WITH APPLICATOR
4NDC:62001-0318-4113 g in 1 TUBE
5NDC:62001-0318-54 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/24/2004
Labeler - Straight Arrow Products, Inc. (061580593)
Registrant - Straight Arrow Products, Inc. (061580593)
Establishment
NameAddressID/FEIBusiness Operations
Straight Arrow Products, Inc.061580593manufacture

Revised: 9/2010
Document Id: 0e9551ee-2843-451b-9c48-5cebdfcb75c8
Set id: e626d2cc-caf8-4515-9959-d2def58c7be3
Version: 1
Effective Time: 20100927
 
Straight Arrow Products, Inc.