Remedy Nails by Adwill Labs Inc / PhytogenX, Inc. DRUG FACTS

Remedy Nails by

Drug Labeling and Warnings

Remedy Nails by is a Otc medication manufactured, distributed, or labeled by Adwill Labs Inc, PhytogenX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REMEDY NAILS- undecylenic acid lotion 
Adwill Labs Inc

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.

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DRUG FACTS

ACTIVE INGREDIENT:

Undecylenic Acid USP 10%

PURPOSE:

Anti-Fungal

USES:

Treats cuticle and skin fungal infections.

• Heals and moisturizes cuticles and skin.
• Athlete's foot treatment.
• Relieves itching, burning and cracking.

WARNINGS: FOR EXTERNAL USE ONLY.

Keep out of reach of children.

• Consult your doctor if you are pregnant before using this product.
• It is not known whether this drug passes into breast milk.
• Consult your doctor before breast feeding.
• If swallowed, call Poison Control Center immediately.

STOP USE AND ASK A DOCTOR IF:

Irritation occurs.

• No improvement within 2 weeks.

DIRECTIONS:

Wash and dry affected area.

• Apply a thin layer over affected area twice daily or as directed by a doctor.
• Apply enough medication to cover the affected area and surrounding skin.
• Wash hands after use.
• For maximum results, use twice daily or as instructed.
• Discontinuing use of this medication may allow recurrence of infection.
• If condition persists, consult your doctor.

CAUTION:

Do not accept if safety seal is broken or missing.

• Store at room temperature 60-85F.
• Keep in tight, light resistant container.

ALLERGIC REACTIONS:

Contact doctor if unusual reactions to this medicine occur.

• This product does not contain FD&C Yellow #5 or FD&C Yellow #6.

INACTIVE INGREDIENTS:

Mineral Oil, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Linalool, Carthamus Tinctorius (Safflower) Seed Oil, Limonene, Aleurites Moluccana (Kukui) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Algae Extract.

Principal Display Panel - 15 mL Bottle Label

Dr.'s REMEDY®
Therapeutic Cuticle Oil

Lavender
Safflower
Tea Tree Oil
Algae Extract

Nourishing
Anti-Fungal
Treatment

15mL

REMEDY NAILS 
undecylenic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72222-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	85 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SAFFLOWER OIL (UNII: 65UEH262IS)
TEA TREE OIL (UNII: VIF565UC2G)
GRAPE SEED OIL (UNII: 930MLC8XGG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72222-224-10	1 in 1 CARTON	06/01/2018
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/01/2018

Labeler - Adwill Labs Inc (081136982)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	manufacture(72222-224)

Revised: 11/2019

Document Id: 984843a5-41e1-432d-e053-2995a90abbed

34390-5

Set id: 4e87b76c-c430-466a-bc30-fe1785c7c660

Version: 2

Effective Time: 20191126

 

Adwill Labs Inc