Label: REMEDY NAILS- undecylenic acid lotion
- NDC Code(s): 72222-224-10
- Packager: Adwill Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated May 22, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT:
- PURPOSE:
- USES:
- WARNINGS: FOR EXTERNAL USE ONLY.
- STOP USE AND ASK A DOCTOR IF:
-
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:
- ALLERGIC REACTIONS:
- INACTIVE INGREDIENTS:
- Principal Display Panel - 15 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
REMEDY NAILS
undecylenic acid lotionProduct 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)