DR. LUKE MOLLUSCUM WART REMOVER- molluscum wart remover liquid 
Dr.luke Healthcare LLC

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.

----------

83176-008-01
DR. LUKE MOLLUSCUM WART REMOVER

Active Ingredient

Salicylic Acid 1%
Chlorhexidine Acetate 1%

Purpose

Wart Remover
Antivira

Use

For genital wart, molluscum contagiosum, and small size skin tag,common wart, flat wart, filiform wart

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

lf you are pregnant, breastfeeding
If you are allergic to this product
On children under 10 years
On unhealed wounds after surgery

WHEN USING SECTION

For external use only, don't contact with eyes or swallow.
Children should use it under the supervision of adults.
Keep out of reach of children.
The liquid can get easily volatilized & crystallized, tighten the cap after use.
Avoid long-term contact with air while using.

STOP USE section

you are experiencing severerash, edema, or severe painallergic reactions, local ulcers, heavy

ASK DOCTOR

you are experiencing severerash, edema, or severe painallergic reactions, local ulcers, heavy

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

Cortex Phellodendri, Chinensis, Radix lsatidis, Radix Arnebiae.Semen Coicis Carthamus Tinctorius L, Angelica Sinensis,Rhizoma Chuanxiong, Crassostrea Gigas.

QUESTIONS?

nfoadrlukehealthcare.com
www.drlukehealthcare.com

PRINCIPAL DISPLAY PANEL

83176-008-01

83176-008-01

DR. LUKE MOLLUSCUM WART REMOVER 
molluscum wart remover liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE (UNII: R4KO0DY52L) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE1 mg  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83176-008-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02804/17/2023
Labeler - Dr.luke Healthcare LLC (118868014)
Establishment
NameAddressID/FEIBusiness Operations
Dr.luke Healthcare LLC118868014label(83176-008) , manufacture(83176-008)

Revised: 4/2023
Document Id: f99dd6bb-ff19-a50d-e053-6294a90ae53c
Set id: f99dd6bb-ff18-a50d-e053-6294a90ae53c
Version: 1
Effective Time: 20230418
 
Dr.luke Healthcare LLC