CHLORASEPTIC WARMING SORE THROAT- phenol spray 
Denison Pharmaceuticals, 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 anesthetic/Analgesic

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 administer 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 doctor before use.

Keep out of reach of children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Adults and children 6 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 6 years of age: consult a doctor or dentist.

Other information

  • Store at room temperature.
  • Check expiration date before using.
  • Contains FD&C yellow 5 (tartrazine) as a color additive

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 Chloraseptic.com


PRINCIPAL DISPLAY PANEL

Chloraseptic Warming Sore Throat Spray
Phenol/Oral Anesthetic
Honey Lemon Flavor | 6 FL OZ (177 mL)

Chloraseptic Warming Sore Throat Spray Phenol/Oral Anesthetic Honey Lemon Flavor | 6 FL OZ (177 mL)

CHLORASEPTIC WARMING SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1026
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 mg  in 100 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:0295-1026-231 in 1 BOX01/01/2017
1177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35601/01/2017
Labeler - Denison Pharmaceuticals, Inc. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208MANUFACTURE(0295-1026)

Revised: 5/2017
Document Id: f49b6e1e-e825-4936-95cc-15df268dc2a9
Set id: 782759c2-4755-411f-bb4d-aa9a1b3db442
Version: 2
Effective Time: 20170503
 
Denison Pharmaceuticals, Inc.