Label: RAW HEAT- menthol liquid

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated January 30, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 3.5%

  • Purpose

    Pain Reliever

  • Uses

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

  • 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.

  • 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.

  • Inactive Ingredients

    Aloe Barbadensis (Aloe) Leaf Gel, SDA 38B, Glycerin, Xanthan Gum, Gaultheria Procumbens (Wintergreen) Leaf Oil, Cinnamomum Cassia (Cassia) Oil, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria), Organic Symphytum Officinalis (Comfrey)

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

  • Questions or comments:

    Email us at: info@rawhealthintl.com

    MSRP $14.99

  • PRINCIPAL DISPLAY PANEL – 3 oz. bottle

    RAW
    RAW HEALTH INTERNATIONAL

    HEAT

    The All-Natural
    Warming Pain Reliever

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

    3 fl OZ / 89 mL

    www.rawhealthintl.com
    Also Try RAW-ICE for cooling pain relief

    PRINCIPAL DISPLAY PANEL – 3 oz. bottle
  • INGREDIENTS AND APPEARANCE
    RAW HEAT 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55413-2501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol34.86 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    glycerin (UNII: PDC6A3C0OX)  
    xanthan gum (UNII: TTV12P4NEE)  
    methyl salicylate (UNII: LAV5U5022Y)  
    chinese cinnamon oil (UNII: A4WO0626T5)  
    camphor oil (UNII: 75IZZ8Y727)  
    matricaria recutita (UNII: G0R4UBI2ZZ)  
    symphytum uplandicum leaf (UNII: D05HXK6R3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55413-2501-10.089 L in 1 BOTTLE
    2NDC:55413-2501-20.118 L in 1 BOTTLE
    3NDC:55413-2501-30.004 L in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/15/2013
    Labeler - Raw Health International, LLC (014982454)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(55413-2501)
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