Dr. Luke Molluscum Wart Remover by Dr.luke Healthcare LLC 83176-008-01 Completed

Drug Details [pdf]

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

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83176-008-01 Completed

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

DR. LUKE MOLLUSCUM WART REMOVER
molluscum wart remover liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83176-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
COPTIS DELTOIDEA ROOT (UNII: 1UIP402HTI)
ARNEBIA GUTTATA ROOT (UNII: 9XN41J8M2D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 83176-008-01	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M028	04/17/2023	11/21/2024

Labeler - Dr.luke Healthcare LLC (118868014)

Name	Address	ID/FEI	Business Operations
Establishment
Dr.luke Healthcare LLC		118868014	label(83176-008) , manufacture(83176-008)

Revised: 11/2024

Document Id: 2764822b-1423-841b-e063-6294a90a231a

Set id: f99dd6bb-ff18-a50d-e053-6294a90ae53c

Version: 2

Effective Time: 20241120