Label: PAIN RELIEVING ROLL-ON- menthol, camphor, capsaicin lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 19, 2022

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  • Warnings:

    For external use only

  • DOSAGE & ADMINISTRATION

  • Purpose

    Pain Reliever

  • Other Information

    Store in a cool dry place with lid or cap closed tightly.
    Flammable: Keep away from excessive heat or open flame

  • Active Ingredient

    Menthol USP 3.85%

    Camphor USP 3.85%

    Capsaicin USP 0.0355%

  • Directions

    Adults and children 2 years and older:
    Apply a small amount directly on the skin over the affected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more than 4 times daily.
    Children under 2 years of age: Consult a Physician

  • Keep Out of Reach of Children

    In case of accidental ingestion get medical help or contact a Poison Control Center immediately

  • Inactive Ingredients

    Aloe Vera, Arnica Extract, Boswellia Serrata Extract, Green Tea Extract, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Orange Fruit Extract, Grapefruit Extract, Dimethyl Sulfone, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis Leaf Extract, Phenoxyethanol, Purified Water, Rose Extract, Vitamin E, Triethanolamine, Yucca Extract

  • Uses

    Temporary relieves minor aches and pains associated with

    • sore muscles and joints
    • arthritis
    • backache
    • muscle strains
    • sprains
    • bruises
  • When using this product:

    Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointment, creams, sprays or liniments. After applying wash hands thoroughly with cool water

  • Stop use and ask a doctor if:

    Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritatio develops

  • If Pregnant or Breast Feeding:

    Ask a health professional before use

  • This product contains Capsaicin

    and may cause temporary burning, stinging, inflammation, redness or welts on the application site thatususally disappear in a few days. If you experience any of these symptoms discontinue use and contact your doctor immediately

  • PDP

    CryoDerm

    HEAT

    PAIN RELIEVING

    WARMING Therapy

    ROLL-ON

    Fast, Deep Penetrating Pain Relief for:

    Muscle Strains, Joint Pain, Backache, Arthritis, Sprained Ligaments & Bruises

    Paraben Free / Propylene Glycol Free / Aspirin Free
    NSAID Free / Silicone Dioxide Free / Gluten Free

    Contains Essential Oils & Natural Extracts

    MSM Arnica Boswellia Ilex


    Active Ingredients:
    Menthol . Camphor . Capsaicin

    3 fl.oz. 84mL

    Cryoderm Heat Roll on

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING ROLL-ON 
    menthol, camphor, capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.85 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.85 g  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0355 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 77.3645 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
    ARNICA MONTANA (UNII: O80TY208ZW) 0.5 mL  in 100 mL
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) 0.5 mL  in 100 mL
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.5 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1 mL  in 100 mL
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) 1 mL  in 100 mL
    CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O) 0.5 mL  in 100 mL
    GRAPEFRUIT (UNII: O82C39RR8C) 0.5 mL  in 100 mL
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) 3.5 mL  in 100 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.3 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) 0.5 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.7 mL  in 100 mL
    ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) 0.5 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.5 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL  in 100 mL
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC) 0.5 mL  in 100 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68678-040-9084 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2016
    Labeler - AHC VENTURES CORP DBA CRY (131871779)
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