Label: HESHOUTANG PURAFLEX OMNIRELIEF- peppermint oil/menthol 2% spray

  • NDC Code(s): 84246-995-88
  • Packager: Shandong Huawei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 21, 2024

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

View All Sections
  • ACTIVE INGREDIENT

    Peppermint Oil/Menthol 2%

  • PURPOSE

    External Analgesic/Nasal Decongestant

  • USES

    Temporary relief of minor aches & pains due to:-arthritis-simple backache-strains-bruises-sprains-sore throat-toothache-wounds-insects bite/sting;

    Temporary relief of nasal congestion due to:-common cold-sinusitis-respiratory tract infections-upper respiratory allergies-weather changes.

  • WARNINGS

    Do not use-on eyes-if excessive irritation develops-if allergic to any of the ingredients

  • WHEN USING THIS PRODUCT

    do not share nozzle-do not exceed recommended dosage-two nozzles included: one for the nose and one for other uses

  • STOP USE AND ASK A DOCTOR IF

    condition worsens-symptoms persist

  • ASK A DOCTOR BEFORE USE IF

    you have serious chronic diseases-you are pregnant or breast-feeding-you are menstruating-you are using for your children under 3 years of age.

  • KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING:

    In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • DIRECTIONS

    With the head held upright, remove the protective cap,

    Use for nasal congestion-1. Blow your nose to clear up the passageways,-2. Block one nostril, insert the nasal nozzle into the other nostril,-3. Depress the pump 2-3 times, breathe in gently;

    Use for toothache-1. Insert the spare nozzle near the painful tooth,-2. Depress the pump 2-3 times on the tooth;

    Use for muscle & joints pain-1. Place the spare nozzle near the painful area,-2. Depress the pump 2-3 times on the affected skin, and massage until the skin is dry,-3. Repeat for about 3-5 minutes;

    Use for wound pain-1. Place the spare nozzle near the wound,-2. Depress the pump 2-3 times on the wound,-3. Dress the wound with an adhesive bandage;

    Use for sore throat-1. Place the spare nozzle into the mouth,-2. Depress the pump 2-3 times into the throat;

    Repeat up to 3 times daily.

  • OTHER INFORMATION

    Store between 20°-25°C (68°-77°F)-The container is filled to the proper level for best spray action.

  • INACTIVE INGREDIENTS

    Xanthium Sibiricum Fruit, Magnolia Biondii Flower, Angelica Dahurica Root, Asarum Heterotropoides Root, Borneol, Purified Water.

  • QUESTIONS OR COMMENTS? (602) 368-7231

    M-F, 9:30 am to 5:30 pm Pacific Time - You may also report serious side effects to this phone number.

  • MANUFACTURED FOR HESHOUTANG PRODUCTS LLC

    9035 N 43rd Ave, Phoenix, AZ 85051, USA
    www.heshoutang.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    PuraFlex OmniRelief Spray

  • INGREDIENTS AND APPEARANCE
    HESHOUTANG PURAFLEX OMNIRELIEF 
    peppermint oil/menthol 2% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84246-995
    Route of AdministrationTOPICAL, NASAL, DENTAL, OROPHARYNGEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.8 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASARUM HETEROTROPOIDES ROOT (UNII: Q94BWI90CD)  
    MAGNOLIA BIONDII FLOWER (UNII: G1YA92798O)  
    WATER (UNII: 059QF0KO0R)  
    BORNEOL (UNII: M89NIB437X)  
    XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84246-995-8860 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/18/2024
    Labeler - Shandong Huawei Pharmaceutical Co., Ltd. (417377581)
    Registrant - Heshoutang Products LLC (072967484)
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!