NAIL ACTIVE DAYTIME ANTI-FUNGAL- tolnaftate lotion 
Harvest Trading Group 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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Nail Active Daytime Anti-Fungal Lotion

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses for effective treatment of most athlete's foot (tinea pedis).  Relieves

  • itching
  • scaling
  • cracking
  • burning
  • redness

Warnings.  For external use only.

Do not use on children under 2 years of age unless directed by doctor.

Stop use and ask doctor if irritation occurs or if there is no improvement within 4 weeks.

When using this product avoid contact with eyes

  • If contact occurs rinse thoroughly with water

If pregnant or nursing, seek the advice of a health professional before using.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between toes; wear well-fitting ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks.  If condition persists longer, consult a doctor.
  • this product is not effective on the scalp or nails.

Inactive ingredients Water (Aqua), Glyceryl Stearate SE, Glycerin, Ceteareth 20, Mineral Oil, Cetearyl Alcohol, Propylene Glycol, Aloe Barbadensis Leaf Juice, Arginine HCl, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Ascorbic Acid, Dimethicone, Titanium Dioxide, Retinyl Palmitate, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance.

Nail Active

Daytime

anti-fungal

lotion

Relieves Itching,

Cracking, Burning

2 FL OZ (59 mL)

Nail Active Lotion Label

NAIL ACTIVE DAYTIME ANTI-FUNGAL 
tolnaftate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59002-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE100 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
TEA TREE OIL (UNII: VIF565UC2G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59002-112-0159 g in 1 TUBE; Type 0: Not a Combination Product03/17/201411/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/17/201411/14/2016
Labeler - Harvest Trading Group Inc. (613203728)

Revised: 2/2017
Document Id: d14c1f73-8467-4c6e-8c4b-f3a581f22c16
Set id: b8320b4f-45df-462a-a221-7ac2c508709c
Version: 2
Effective Time: 20170206
 
Harvest Trading Group Inc.