Ingrown Nail Treatment by Consilii LLC 83299-029 Completed

Ingrown Nail Treatment by

Drug Labeling and Warnings

Ingrown Nail Treatment by is a Otc medication manufactured, distributed, or labeled by Consilii LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INGROWN NAIL TREATMENT- jalawef ingrown nail treatment liquid 
Consilii LLC

----------

83299-029 Completed

Active Ingredient

Clove oil 6%

Cnidium Monnieri Extract 5%

Purpose

Ingrown Toenail Treatment

Use

(Usage)
1.Cleanse and dry affected nails.

2.Directly apply the product to the affected area (you can use a cotton swab for application).

3.Place the nail patch over the affected area and allow it to soften.

4. After softening the nail, use the file to shape the nail.

Warnings

For external use only

Keep out of the reach of children.

Do not use

Avoidcontact with eyes and mouth. Donot use it on the irritated skin. Notsuitable for pregnant andbreastfeeding.

When Using

Apply the product directly to the affected area (can be used with a cotton swab).

Stop Use

lf swallowed, get medicalassistance or contact the poison control center.

Ask Doctor

lf swallowed, get medicalassistance or contact the poison control center.

Keep Oot Of Reach Of Children

Keep out of the reach of children.

Directions

DIRECTION:
Wash and dry affected nails
Apply the product directly to the affected area (can be used with a cotton swab).
Place the nail patch over the affected area and wait for it to soften.
After softening the nail, use the file to shape the nail.

Other information

store at room temperature

avoid excessive heat 37°C (99°F)

Inactive ingredients

Aloe vera 5%
Salicylic acid 5%
Ethanol 30%
Purified water 22%
Eugenol 10%
Shea butter 12%
Lactic Acid 5%

Questions

1-9146081258

PRINCIPAL DISPLAY PANEL

INGROWN NAIL TREATMENT 
jalawef ingrown nail treatment liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83299-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS) (CNIDIUM MONNIERI FRUIT - UNII:V1IA3S3CUS)	CNIDIUM MONNIERI FRUIT	5 g  in 100 mL
CLOVE OIL (UNII: 578389D6D0) (CLOVE OIL - UNII:578389D6D0)	CLOVE OIL	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SALICYLIC ACID (UNII: O414PZ4LPZ)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
ALCOHOL (UNII: 3K9958V90M)
EUGENOL (UNII: 3T8H1794QW)
LACTIC ACID (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83299-029-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/13/2024	11/21/2024

Labeler - Consilii LLC (118891890)

Establishment
Name	Address	ID/FEI	Business Operations
Consilii LLC		118891890	label(83299-029) , manufacture(83299-029)

Revised: 11/2024

Document Id: 2763d659-ea34-c2ee-e063-6394a90af99a

34390-5

Set id: 1ac2d7fc-1806-7925-e063-6294a90ad3b5

Version: 2

Effective Time: 20241120

 <