Label: SORE THROAT- phenol spray
- NDC Code(s): 68163-703-06
- Packager: Raritan Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
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 2, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use(s)
- Warnings
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast feeding
- Keep out of reach of children
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Directions
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Adults and children 12 years of age and older:
Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, and then spit out. - ▪
- Use every 2 hours or as directed by a doctor or dentist.
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- Children 6 years to under 12 years of age: should be supervised in the use of this product.
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- Children under 6 years: Consult a doctor or dentist.
- Other Information
- Inactive Ingredients
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Principal Display Panel
*Compare to the active ingredient in Chloraseptic®
NDC# 68163-703-06
SORE THROAT SPRAY
Phenol/Oral Pain Reliever
Fast Acting
Numbs on Contact
SUGAR-FREE
ASPIRIN-FREE
NATURAL CHERRY FLAVOR
6 FL OZ (177 mL)
Tamper-Evident: Do not use if imprinted shrink band is broken or missing.
Distributed by:
*This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.
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INGREDIENTS AND APPEARANCE
SORE THROAT
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-703 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 FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED Score Shape Size Flavor CHERRY (Natural Cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-703-06 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/29/2020 Labeler - Raritan Pharmaceuticals Inc (127602287)