Heshoutang

Manufacturer
Shandong Huawei Pharmaceutical Co., Ltd. | Heshoutang Products LLC
Effective date
2024-06-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:13:59

Label at a glance#

ProductHeshoutang PuraFlex OmniRelief
Active ingredientMENTHOL
Label structure14 sections

Indications and 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.

Dosage and administration

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 ne...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Peppermint Oil/Menthol 2%

PURPOSE

OTC - PURPOSE SECTION

External Analgesic/Nasal Decongestant

USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

condition worsens-symptoms persist

ASK A DOCTOR BEFORE USE IF

OTC - ASK DOCTOR SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

QUESTIONS OR COMMENTS? (602) 368-7231

INFORMATION FOR OWNERS/CAREGIVERS SECTION

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

HEALTH CARE PROVIDER LETTER SECTION

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

Made in China

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PuraFlex OmniRelief SprayPuraFlex OmniRelief Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84246-995-88Heshoutang PuraFlex OmniRelief60 mL in 1 BOTTLE, SPRAYSPRAY603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84246-995HESHOUTANG PURAFLEX OMNIRELIEF (PEPPERMINT OIL/MENTHOL 2%) SPRAY [SHANDONG HUAWEI PHARMACEUTICAL CO., LTD.]31 package rows20240623_1ae25a15-b35b-3a10-e063-6394a90a74a3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84246-99584246-995-88

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1b724672-b803-290b-e063-6394a90a0d981ae25a15-b35b-3a10-e063-6394a90a74a32024-06-21WarningsExact identifier
spl id: 1b724672-b803-290b-e063-6394a90a0d98
spl set id: 1ae25a15-b35b-3a10-e063-6394a90a74a3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.