Label: DR. LUKE MOLLUSCUM WART REMOVER- molluscum wart remover liquid
- NDC Code(s): 83176-008-01
- Packager: Dr.luke Healthcare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 April 18, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only.
Children need to use it under adult supervision.
Please tighten the cap immediately after using it.
Avoid contact with eyes, flush with water immediately if it getsinto eyes.
A small number of users may experience a slight burning ortingling sensation after use..
Minor rash and swelling reactions may occur, needn't stop using - Do not use
- WHEN USING SECTION
- STOP USE section
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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Directions
1. Wash wart and surrounding skin with rubbing alcohol orastringent solution (e.g.: Potassium Permanganate solution), anddry the area thoroughly.
2. Apply a small amount of liquid solution onto the wart with acotton swab, and press the wart 2-3 times. Avoid applying onhealthy skin.
3. Do not apply the liquid over 1 ml onto the affected area. Afterapplying, let the affected area dry.
4. Use once in the morning and evening continuously for 7 daysThe wart will begin to fall off after the last day of treatment. stopusing, and observe for 3 days.Repeat the treatment p rocess if the wart has not yet fallen off.lf swallowed,rinse immediately with water, and get medicalhelp or contact a poison control center right away
- Inactive ingredients
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. LUKE MOLLUSCUM WART REMOVER
molluscum wart remover liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83176-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE (UNII: R4KO0DY52L) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE 1 mg in 100 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 mg in 100 mL Inactive Ingredients Ingredient Name Strength ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX) COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI) PHELLODENDRON CHINENSIS BARK (UNII: 2866QMZ434) CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) PACIFIC OYSTER (UNII: FX2S0D3781) ARNEBIA GUTTATA ROOT (UNII: 9XN41J8M2D) COPTIS DELTOIDEA ROOT (UNII: 1UIP402HTI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83176-008-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M028 04/17/2023 Labeler - Dr.luke Healthcare LLC (118868014) Establishment Name Address ID/FEI Business Operations Dr.luke Healthcare LLC 118868014 label(83176-008) , manufacture(83176-008)
