Label: RAW ICE- menthol liquid 

  • NDC Code(s): 55413-2500-1, 55413-2500-2, 55413-2500-3
  • Packager: Raw Health International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Menthol 3.5%

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  • Purpose

    Pain Reliever

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  • Uses

    Temporarily relieves minor pain associated with: muscle sprains, muscle strains, neck/back aches/pains, sore joints, arthritis, cramps and bruises.

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  • Warnings

    For external use only. Flammable. Keep away from open flame or extreme heat.

    Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

    When using this product: Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

    Do not use with a heating pad or other ointments, creams, sprays or liniments. Do not apply to irritated skin. Wash hands thoroughly after each application.

    Stop use and ask a health professional if condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, or if irritation occurs. If pregnant or breast feeding ask a health care professional before use. Store at room temperature.

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  • Directions

    For adults and children 6 years of age and older: Shake well. Clean skin. Apply a liberal amount of gel directly on the skin over the affected area until absorbed into skin. Repeat as necessary, but not more than 4 times daily. May also be applied before or after activity. For children under 6 years of age, consult a health care professional.

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  • Inactive Ingredients

    Aloe Barbadensis (Aloe) Leaf Gel, SDA 38B, Glycerin, Mentha Piperita (Peppermint) Oil, Xanthan Gum, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria) Flower Extract, Organic Symphytum Officinalis (Comfrey)

    RAW Health International, LLC
    91 Ft. Couch Road-Pittsburgh, PA 15241
    www.rawhealthintl.com
    Ph: 1-888-RAW-HLTH

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  • Questions or comments:

    Email us at: info@rawhealthintl.com

    MSRP $14.99

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  • PRINCIPAL DISPLAY PANEL – 3 oz. bottle

    RAW
    RAW HEALTH INTERNATIONAL

    ICE

    The All-Natural
    Cooling Pain Reliever

    Muscle Strains,
    Joint Sprains, Neck/Back Aches,
    Pains and Much More…

    3 fl OZ / 89 mL

    www.rawhealthintl.com
    Also Try RAW-HEAT for warming pain relief

    PRINCIPAL DISPLAY PANEL – 3 oz. bottle
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  • INGREDIENTS AND APPEARANCE
    RAW ICE 
    menthol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55413-2500
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    menthol (menthol) menthol 34.79 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    aloe vera leaf  
    glycerin  
    peppermint oil  
    xanthan gum  
    camphor oil  
    matricaria recutita  
    symphytum uplandicum leaf  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55413-2500-1 0.089 L in 1 BOTTLE
    2 NDC:55413-2500-2 0.118 L in 1 BOTTLE
    3 NDC:55413-2500-3 0.004 L in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/15/2013
    Labeler - Raw Health International, LLC (014982454)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(55413-2500)
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