Label: NEVERPAIN- menthol spray

  • 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 February 2, 2017

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  • SPL UNCLASSIFIED SECTION

    ANC NEVERPAIN

    FOR EXTERNAL USE ONLY

    Neverpain is a natural, deep penetrating, fast acting pain reliever free of suspected carcinogens and coloring agents. It is a nutrient in bone and muscle tissue.

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

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

    ▪ simple backache

    ▪ arthritis

    ▪ strains

    ▪ bruises

    ▪ sprains

  • WARNINGS

    Warnings
    For external use only.

    Avoid contact with the eyes.

  • STORAGE AND HANDLING

    Flammable, keep away from fire or flame.

  • WHEN USING

    When using this product

    ▪ do not apply to wounds or damaged skin
    ▪ do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
    •  redness is present.
    •  excessive irritation of the skin develops.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and older. Apply to the affected area not more than 3 to 4 times daily.
    •  Children under 2 years of age: Consult a physician.
  • INACTIVE INGREDIENT

    Inactive ingredients
    Alcohol, aloe vera extract, camphor, copaiba, natural eucalyptus, natural passionflower and peppermint,

  • SPL UNCLASSIFIED SECTION

    Do not contain steroids

  • QUESTIONS

    Questions?
    Contact (212) 354-9702,
    (M-F 10:00 am - 5:00 pm)

  • SPL UNCLASSIFIED SECTION

    NDC: 75974-200-01 & 75974-200-03

    MADE IN USA BY

    ANC Amazon Natural Corp.
    265 W. 37th St., Suite 307-A
    New York, NY 10018

    www.neverpain.com

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH

    EXTERNAL ANALGESIC

    NEVERPAIN

    SPRAY

    NeverPain

  • INGREDIENTS AND APPEARANCE
    NEVERPAIN 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75974-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)  
    EUCALYPTUS GUM (UNII: 72T9EZC2VX)  
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75974-200-0129.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2016
    2NDC:75974-200-038 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/11/2016
    Labeler - ANC Amazon Natural Corp. (066551537)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANC Amazon Natural Corp.066551537manufacture(75974-200)
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