CHLORASEPTIC WARMING SORE THROAT- phenol spray 
Prestige Brands Holdings, Inc.

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.

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Chloraseptic Warming Sore Throat Spray

Drug Facts

Active ingredient

Phenol 1.4%

Purpose

Oral pain reliever

Uses

for the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Warnings

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 3 years of age unless directed by a doctor.

When using this product

do not exceed recommended dosage.

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 3 years of age and older:

Other information

Inactive ingredients

caramel color, citric acid, FD&C yellow no. 5, FD&C yellow no.6, glycerin, flavors, purified water, saccharin sodium, sodium citrate, sucralose

Questions?

1-800-552-7932


PRINCIPAL DISPLAY PANEL

Chloraseptic
w
arming
SORE THROAT


H
ONEY LEMON 6 FL OZ (177 mL) SPRAY

PRINCIPAL DISPLAY PANEL
Chloraseptic
warming
SORE THROAT

HONEY LEMON 6 FL OZ (177 mL) SPRAY

CHLORASEPTIC WARMING SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL3.5 mg  in 0.7 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67172-212-31177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2012
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(67172-212)

Revised: 4/2023
Document Id: 838978be-fbb7-4b2b-9916-20462a04cb8f
Set id: a197fab2-70ce-4a6c-9add-29d7368a75c5
Version: 8
Effective Time: 20230425
 
Prestige Brands Holdings, Inc.