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
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- 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:
-
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
- INACTIVE INGREDIENTS
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INGREDIENTS AND APPEARANCE
HESHOUTANG PURAFLEX OMNIRELIEF
peppermint oil/menthol 2% sprayProduct 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)