Active Ingredient
Peppermint Oil/Menthol 2%
Heshoutang Puraflex Omnirelief
FDA Label NDC 84246-995
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shandong Huawei Pharmaceutical Co., Ltd. for the product Heshoutang Puraflex Omnirelief (NDC 84246-995). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, ask a doctor before use if, keep out of reach of children. overdose warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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