Label: SORE THROAT- phenol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 70005-035-01 - Packager: We Care Distributor Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 September 23, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Sore throat warning: Severe or 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.
When using this product
- do not exceed recommended dose
- do not use for more than 2 days, Use only as directed
- use of this container by more than one person may spread infection
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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 its dust cap from the tip. To spray, hold bottle straight up and press on 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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SORE THROAT
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 1.4 g in 100 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color RED (clear) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70005-035-01 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/23/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/23/2016 Labeler - We Care Distributor Inc. (079832998) Establishment Name Address ID/FEI Business Operations PURINE PHARMA LLC 019950491 manufacture(70005-035)
