Label: SINUS BUSTER - red pepper spray
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- NDC Code(s): 22955-014-20
- Packager: SiCap Industries LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated 04/10
If you are a consumer or patient please visit this version.
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- PURPOSE
- INDICATIONS & USAGE
Uses: For the Temporary Relief of:
- Sinus Congestion
- Nasal Congestion
- Sinus Pressure and Headache
- WARNINGS
For nasal use only. Upon initial use, you will experience a powerful sensation which lasts a few seconds. This sensation is inherent to the process that allows the capsaicin to work. Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may result.
Close - ASK DOCTOR
Ask a doctor before use if you have:
- ever had any medical procedures relating to your nose or sinuses, or you're susceptible to nose bleeds
- allergies to any of the ingredients.
- WHEN USING
When using this product:
- Avoid contact with the eyes, In case of accidental contact with eyes, flush with water (and immediately seek professional help).
- The use of this container by more than one person may spread infection.
- STOP USE
Stop use and ask doctor if symptoms persist more than two weeks or worsen or if you experience dizziness or hear palpitations.
Close - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Close - DOSAGE & ADMINISTRATION
Directions:
- Adults and children 12 years of age and older: use as needed at the first sign of symptoms. Pump 1-3 times in each nostril.
- Children under 12 years of age: Consult a doctor before use.
To use pump: Shake well. Remove cap and safety clip. Hold with thumb at bottom of bottle and place nozzle between fingers. Before using the first time, prime pump by depressing several times. Insert nozzle into nostril and firmly depress rim. Sniff deeply.
Close - STORAGE AND HANDLING
- Store at room temperature 15-29 degrees C (59-84 degrees F)
- Retain carton for future reference on full labeling
- INACTIVE INGREDIENT
Ascorbic Acid (Crystallized Vitamin C), Eucalyptol, Purified Water, Rosemary Extract, Sea Salt, Vegetable Glycerin
Close - QUESTIONS
- PRINCIPAL DISPLAY PANEL
100% Natural Chemical Free
Non-drowsy
No Known Drug Interactions
Non-habit Forming
Relieves:
- Sinus Congestion
- Nasal Congestion
- Sinus Pressure and Headache
Made in the USA
Not tested on Animals
Distributed by:
SiCap LLC
Albany New York 12205
A wholly owned subsidiary of Dynova Laboratories
www.BusterBrands.com
Close - INGREDIENTS AND APPEARANCE
SINUS BUSTER
capsicum annuum sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:22955-014 Route of Administration NASAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RED PEPPER (UNII: 6M47G7C4SY) (RED PEPPER - UNII:6M47G7C4SY) RED PEPPER 4 [hp_X] in 20 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:22955-014-20 20 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/31/2008 Labeler - SiCap Industries LLC (170665298) Registrant - SiCap Industries LLC (170665298) CloseEstablishment Name Address ID/FEI Business Operations SiCap Industries LLC 170665298 manufacture
