GOLD MOUNTAIN BEAUTY FUNGAL NAIL ELIMINATOR- tolnaftate antifungal oil 
Renu Laboratories, 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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Gold Mountain Beauty Fungal Nail Eliminator

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

For external use only

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Other information

Store at room temperature (59 - 86 degrees F)

Inactive ingredients

C12-15 Alkyl Benzoate, Ethyldiglycol, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Oil, Trimethylpentanediol/Adipic Acid Copolymer

For questions or comments, please visit: goldmountainbeauty.com

Trim nails and file the surface using an emery board
Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails
Allow solution to soak into nail or skin
Application to adjacent nails is recommended to prevent the spread of infection
Keep affected areas clean and dry throughout the day
Supervise children in the use of this product

Warnings

For external use only

Directions

GMB_Fungal-Nail-Box Approvedinternal GMB Label_multi layerGOLD MOUNTAIN

Beauty

Foot Therapy

Antifungal

Fungal Nail Eliminator

GOLD MOUNTAIN BEAUTY FUNGAL NAIL ELIMINATOR 
tolnaftate antifungal oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-417
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.14 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
THYME OIL (UNII: 2UK410MY6B)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
WINTER SAVORY OIL (UNII: EP61SM69Z2)  
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TEA TREE OIL (UNII: VIF565UC2G)  
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-417-021 in 1 BOX07/02/2018
1NDC:76348-417-0114 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/02/2018
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories Inc.945739449manufacture(76348-417)

Revised: 1/2022
Document Id: d58ff524-01c2-7574-e053-2995a90a7c52
Set id: 6997ce4b-ead8-00bf-e053-2991aa0a6e08
Version: 9
Effective Time: 20220114
 
Renu Laboratories, Inc.