Label: SORE THROAT CHERRY- phenol spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 68071-1869-6 - 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 February 12, 2021
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
-
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.
-
Directions
- apply to affected area
- use every 2 hours
- allow to remain in place for at least 15 seconds, then spit out
age dose adults and children 12 years and over for each application, spray 5 times children 3 to 11 years should be supervised in use of this product for each application, spray 3 times children under 3 years ask a doctor or dentist - Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SORE THROAT CHERRY
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-1869(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:68071-1869-6 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2017 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(68071-1869)
