Label: RAPID-EASE PAIN RELIEF TOPICAL ANALGESIC- menthol, unspecified form cream

  • 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 September 30, 2019

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 1.25%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches & pains of muscles & joints associated with

    • simple back ache
    • arthritis
    • strains
    • bruises
    • sprains.
  • Warnings

    For external use only.

    Avoid contact with

    • eyes
    • wounds
    • damaged skin
    • do not bandage tightly.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

    If pregnant or breast feeding, ask a health professional before use.

    Stop use and ask a doctor

    • if condition worsens
    • if symptoms persist for more than 7 days
    • if symptoms clear up and occur again within a few days.
  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: consult a doctor.

  • Other information

    • Avoid Ice & NSAID's
    • Store at room temperature
  • Inactive Ingredients

    Arnica1 montana flower extract, Benzyl alcohol, Cetearyl alcohol, Cetearyl glucoside, Dehydroacetic acid, Dimethyl Sulfone (Opti-MSM®), Glycerin (vegetable), Macadamia ternifolia seed oil, Mentha piperita (Peppermint) oil, Persea gratissima (Avocado) oil, Sodium hydroxide, Symphytum officinal (Comfrey1) leaf extract, Tocopheryl acetate (Vitamin E), Water, Xanthan gum.

    1
    Made with organic Arnica & organic Comfrey Leaf
  • Questions?

    Call: 1 (800) 563-1970

    www.rapid-ease.com

  • PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

    • FAST • EFFECTIVE
    • SAFE • NATURAL

    Rapid~Ease™

    Pain
    Relief
    Cream

    For Sprains,
    Strains, Muscle
    & Joint Pain

    1.25% Menthol,
    Arnica & Comfrey Leaf,
    Opti-MSM®

    Helps you heal ~ naturally

    Net Wt. 2.12oz/60g

    PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    RAPID-EASE PAIN RELIEF   TOPICAL ANALGESIC
    menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73347-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form12.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    Dehydroacetic Acid (UNII: 2KAG279R6R)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Macadamia Oil (UNII: 515610SU8C)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Avocado Oil (UNII: 6VNO72PFC1)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73347-117-011 in 1 CARTON09/20/2019
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:73347-117-021 in 1 CARTON09/20/2019
    260 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/20/2019
    Labeler - Rapid-Ease (117162773)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(73347-117)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!