DRUG FACTS

DRUG FACTS

Drug Labeling and Warnings

Drug Details

k">

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.

----------

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

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: 7/2018
 
Adwill Labs Inc


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.