HESHOUTANG PURAFLEX OMNIRELIEF- peppermint oil/menthol 2% spray

Heshoutang PuraFlex OmniRelief by

Drug Labeling and Warnings

Heshoutang PuraFlex OmniRelief by is a Otc medication manufactured, distributed, or labeled by Shandong Huawei Pharmaceutical Co., Ltd., Heshoutang Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HESHOUTANG PURAFLEX OMNIRELIEF 
peppermint oil/menthol 2% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84246-995
Route of Administration	TOPICAL, NASAL, DENTAL, OROPHARYNGEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.8 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84246-995-88	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/18/2024

Labeler - Shandong Huawei Pharmaceutical Co., Ltd. (417377581)

Registrant - Heshoutang Products LLC (072967484)