Label: CHLORASEPTIC SORE THROAT CITRUS- phenol spray
CHLORASEPTIC SORE THROAT CHERRY- phenol spray
CHLORASEPTIC SORE THROAT MENTHOL- phenol spray
- NDC Code(s): 67172-111-31, 67172-112-31, 67172-113-31
- Packager: Prestige Brands Holdings, 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 June 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
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.
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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.
- Apply to the affected area (one spray).
- Other information
- Inactive ingredients
- Questions?
- Active ingredient
- Purpose
- Uses
-
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.
-
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.
- Apply to the affected area (one spray).
- Other information
- Inactive ingredients
- Questions?
- Active ingredient
- Purpose
- Uses
-
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.
-
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.
- Apply to the affected area (one spray).
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CHLORASEPTIC SORE THROAT CITRUS
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-112 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color orange Score Shape Size Flavor CITRUS Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-112-31 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/01/2010 CHLORASEPTIC SORE THROAT CHERRY
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-111 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) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-111-31 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/01/2010 CHLORASEPTIC SORE THROAT MENTHOL
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-113 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 D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color green Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-113-31 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/01/2010 Labeler - Prestige Brands Holdings, Inc. (159655021) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 analysis(67172-112, 67172-111, 67172-113) , label(67172-112, 67172-111, 67172-113) , manufacture(67172-112, 67172-111, 67172-113) , pack(67172-112, 67172-111, 67172-113)
