Label: SORE THROAT CHERRY- phenol spray
- NDC Code(s): 68071-5112-6
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 49348-991
- 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 13, 2022
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- Active ingredient
- Purpose
- Uses
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Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied with 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.
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Directions
- adults and children 6 years of age and older
- apply to affected area (one spray)
- allow to remain in place for at least 15 seconds, then spit out
- use every 2 hours as directed by a doctor or dentist
- children under 12 years of age should be supervised in the use of this product
- children under 6 years of age, consult a doctor or dentist
- adults and children 6 years of age and older
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
SORE THROAT CHERRY
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-5112(NDC:49348-991) 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 ALCOHOL (UNII: 3K9958V90M) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-5112-6 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/30/2014 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-5112)