Label: CARE ONE SORE THROAT- phenol spray
- NDC Code(s): 41520-328-30
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.Close
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 give to children under 3 years of age.
Stop use and ask a doctor or dentist if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Keep out of reach of children.
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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 dentistClose
- Other information
- store at 20-25 oC (68-77 oF)
- Inactive ingredients
FD&C red #40, flavor, glycerin, purified water, saccharin sodiumClose
- Principal Display Panel
Compare to the Active Ingredient in Chloraseptic®
SORE THROAT SPRAY
PHENOL / ORAL ANESTHETIC
Relieves Sore Throat
See New DirectionsClose
- INGREDIENTS AND APPEARANCE
CARE ONE SORE THROAT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-328 Route of Administration ORAL DEA Schedule 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:41520-328-30 177 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/19/2003 Labeler - American Sales Company (809183973)