Label: PHENOL spray
- NDC Code(s): 83324-031-06
- Packager: CHAIN DRUG MARKETING ASSOCIATION INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Purpose
- PURPOSE
- Uses
-
Warnings
Sore throat waring: Severe and persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.
Whan using this product do not exceed recommended dose. Do not use more than 2 days. Use only as directed. Use of this container by more
than one person may spread infection. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
Adults and children 3 years of age and older.
- Apply to the affected area (one spray)
- Allow to remain in place for at least 15 seconds, then spit out
- Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age, consult a doctor or dentist
- Before using the first time, remove the protective neck band and dust cap from the tip. To spray hold bottle straight up and press the
nozzle with index finger without tilting head. Fully depress pump all the way down with a firm, even stroke. Wipe nozzle dry.
- Other information
- Inactive ingredients
-
SPL UNCLASSIFIED SECTION
- Tamper Evident: Do not use if printed shrink band is broken or missing.
- This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic.
Questions or comments?
call 866-200-8310 (Mon-Fri. 9 am-5 pm EST)Distributed by C.D.M.A Inc.
Novi, MI 48375
www.qualitychoice.com
Question: 800-935-2362 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHENOL
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83324-031 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 14 mg in 100 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) SODIUM SACCHARIN (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83324-031-06 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 12/12/2024 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774) Registrant - Seaway Pharma Inc. (117218785) Establishment Name Address ID/FEI Business Operations Seaway Pharma Inc. 117218785 manufacture(83324-031)