Label: PAINAWAY WITH NATURAL PEPPERMINT AND BALSAM PERU- painaway oil

  • 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 December 31, 2019

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

View All Sections
  • ACTIVE INGREDIENT

    Drug Facts

    menthol(2.6%)

    Balsam Peru Oil (2.4%)

    Analgesic in the treatment of muscle pain

  • PURPOSE

    Use

    Helps relieve the condition of pain and stiffness.

  • DOSAGE & ADMINISTRATION

    Dosage Suggestion

    Adults 5ml maximum per day

    Children 1ml maximum per day

  • INDICATIONS & USAGE

    Directions

    Apply on skin and gentle massage around painful area.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    EUCALYPTUS RADIATA LEAF OIL, JAVA CITRONELLA OIL, SUNFLOWER OIL, JOJOBA OIL, ROSEMARY OIL, EVENING PRIMROSE OIL, LEMON OIL, LAVENDER OIL

  • KEEP OUT OF REACH OF CHILDREN

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children.

  • STORAGE AND HANDLING

    Other Information

    Protect this product from excessive heat

    and direct sun.

  • WARNINGS

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children.

  • PainAway-With natural Peppermint and Balsam Peru Oil

    PainAway

  • INGREDIENTS AND APPEARANCE
    PAINAWAY  WITH NATURAL PEPPERMINT AND BALSAM PERU
    painaway oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 mg  in 50 mg
    BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679) BALSAM PERU OIL1.2 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEMON OIL (UNII: I9GRO824LL)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    JAVA CITRONELLA OIL (UNII: DBD92X468R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    Product Characteristics
    Colorpurple (Violet Miron Bottle) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1118-550 mg in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34704/01/2016
    Labeler - PHYTOPIA CO., LTD. (656940504)
    Registrant - BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD. (656368622)
    Establishment
    NameAddressID/FEIBusiness Operations
     BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.656368622manufacture(70470-1118) , label(70470-1118) , pack(70470-1118)
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!