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.

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.

DIRECTIONS:

Wash and dry affected area.

CAUTION:

Do not accept if safety seal is broken or missing.

ALLERGIC REACTIONS:

Contact doctor if unusual reactions to this medicine occur.

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

Principal Display Panel - 15 mL Bottle Label
REMEDY NAILS 
undecylenic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72222-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID85 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72222-224-101 in 1 CARTON06/01/2018
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/01/2018
Labeler - Adwill Labs Inc (081136982)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc.624386772manufacture(72222-224)

Revised: 5/2023
Document Id: d71a5a70-f0e4-45cc-8227-407f577d1fb6
Set id: 4e87b76c-c430-466a-bc30-fe1785c7c660
Version: 12
Effective Time: 20230522
 
Adwill Labs Inc