Label: CARMEX MULTI-SYMPTOM 3 IN 1 COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT- benzocaine, white petrolatum cream
- NDC Code(s): 10210-0048-1
- Packager: Carma Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 25, 2023
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- Drug Facts
- Active Ingredients
- Uses
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Warnings
For external use only
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetic
Stop use and ask a doctor or dentist if
• cold sore symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens • swelling, rash, or fever develops
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Directions
Using clean, dry hands apply 1 to 2 small dollops of Carmex Cold Sore product to the tip of the finger and gently apply and spread evenly to the surface of the cold sore to ensure even coverage over areas of redness. Wash hands thoroughly after application.
Adults and children 2 years of age and older Apply to affected area (lips) not more than 3 to 4 times daily Children 2-12 years of age Should be supervised in use of this product Children under 2 years of age Ask a doctor - Other Information
- Inactive Ingredients:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
CARMEX MULTI-SYMPTOM 3 IN 1 COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT
benzocaine, white petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10210-0048 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 100 mg in 1 g WHITE PETROLATUM (UNII: B6E5W8RQJ4) (BENZOCAINE - UNII:U3RSY48JW5) WHITE PETROLATUM 446.9 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BEHENYL OLIVATE (UNII: NGS1GGK4GW) PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA) MICA (UNII: V8A1AW0880) CALCIUM SILICATE (UNII: S4255P4G5M) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STANNIC OXIDE (UNII: KM7N50LOS6) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10210-0048-1 1 in 1 BLISTER PACK 07/01/2020 1 2 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 Drug M017 07/01/2020 Labeler - Carma Laboratories, Inc. (006090153)