Label: ZILACTIN EARLY RELIEF COLD SORE- benzyl alcohol gel
- NDC Code(s): 72751-0301-1
- Packager: Applied Laboratories, 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 December 1, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
Stop use and ask a physician if
- sore mouth symptoms do not improve in 7 days
- condition worsens or symptoms clear up and occur again within a few days
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- apply only to affected area
- do not exceed recommended dosage
- avoid contact with the eyes
- do not use for more than 7 days unless directed by a physician or dentist
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZILACTIN EARLY RELIEF COLD SORE
benzyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72751-0301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) HYDROXYPROPYL CELLULOSE (1200000 WAMW) (UNII: U3JF91U133) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SALICYLIC ACID (UNII: O414PZ4LPZ) ALCOHOL (UNII: 3K9958V90M) EUCALYPTOL (UNII: RV6J6604TK) THYMOL (UNII: 3J50XA376E) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) TANNIC ACID (UNII: 28F9E0DJY6) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72751-0301-1 1 in 1 CARTON 06/30/2005 1 7.1 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/30/2005 Labeler - Applied Laboratories, Inc. (117337220)