CORN CALLUS REMOVER by Consilii LLC 83299-008 Completed

CORN CALLUS REMOVER by

Drug Labeling and Warnings

CORN CALLUS REMOVER by is a Otc medication manufactured, distributed, or labeled by Consilii LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CORN CALLUS REMOVER- corn callus remover liquid 
Consilii LLC

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83299-008 Completed

Active Ingredient

Salicylic acid 20%
Matrine 2%

Purpose

Corn and callus remover

Use

for the removal of corns and calluses
relieves pain by removing corns and calluses

Warnings

For external use only
Flammable. Keep away from fire and flame.

When Using

if product gets in the eyes, flush with water for 15 minutes
do not inhale vapors
cap bottle tightly and store at room temperature away from heat

Stop Use

discomfort persists

Ask Doctor

discomfort persists

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wash the affected area and dry it thoroughly
apply one drop at a time with the applicator to sufficiently cover each corn/callus
let dry
use a cushion with hole centered over corn or callus to relieve pressure
repeat the procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)
may soak corn/callus in warm water for 5 minutes to assist in removal
protective pads may be used to cushion corn/callus during treatment (additional cushions may be purchased separately)

Other information

store at room temperature away from heat
avoid excessive heat 37°C(99°F)
keep tightly closed

Inactive ingredients

Alcohol, Dried orange peel, Frutus cnidii, Propylene glycol, Purslane, Rhizome of large-headed atractylodes, Root of dahurian angelica, Water, Xanthan gum.

Questions

kronasmile@gmail.com

kronabeauty.com

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

CORN CALLUS REMOVER 
corn callus remover liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83299-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 g  in 100 mL
MATRINE (UNII: N390W430AC) (MATRINE - UNII:N390W430AC)	MATRINE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PURSLANE (UNII: M6S840WXG5)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
ALCOHOL (UNII: 3K9958V90M)
CNIDIUM MONNIERI WHOLE (UNII: GYR30735RE)
ORANGE PEEL (UNII: TI9T76XD44)
ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83299-008-01	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/15/2023	08/29/2024

Labeler - Consilii LLC (118891890)

Establishment
Name	Address	ID/FEI	Business Operations
Consilii LLC		118891890	label(83299-008) , manufacture(83299-008)

Revised: 8/2024

Document Id: 20d16952-4a3f-f5b8-e063-6394a90a65b1

34390-5

Set id: fe3c319c-e74e-3de3-e053-6394a90a7f19

Version: 2

Effective Time: 20240829

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