GOLD MOUNTAIN BEAUTY FUNGAL NAIL ELIMINATOR- tolnaftate antifungal oil

Gold Mountain Beauty Fungal Nail Eliminator by

Drug Labeling and Warnings

Gold Mountain Beauty Fungal Nail Eliminator by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc., Renu Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

For external use only

• Do not use on children under 2 years of age unless directed by a doctor
• Avoid contact with eyes, ears or mouth
• If irritation occurs, discontinue use and consult a doctor
• If swallowed, get medical help or consult a poison control center immediately

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

OTHER SAFETY INFORMATION

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

ASK DOCTOR

• If irritation occurs, discontinue use and consult a doctor

QUESTIONS

For questions or comments, please visit: goldmountainbeauty.com

STOP USE

• If irritation occurs, discontinue use and consult a doctor

INDICATIONS & USAGE

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

Warnings

For external use only

• Do not use on children under 2 years of age unless directed by a doctor
• Avoid contact with eyes, ears or mouth
• If irritation occurs, discontinue use and consult a doctor
• If swallowed, get medical help or consult a poison control center immediately.

DOSAGE & ADMINISTRATION

Directions

• 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

PRINCIPAL DISPLAY PANEL

GOLD MOUNTAIN

Beauty

Foot Therapy

Antifungal

Fungal Nail Eliminator

INGREDIENTS AND APPEARANCE

GOLD MOUNTAIN BEAUTY FUNGAL NAIL ELIMINATOR 
tolnaftate antifungal oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-417
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.14 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
OLIVE OIL (UNII: 6UYK2W1W1E)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
THYME OIL (UNII: 2UK410MY6B)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
WINTER SAVORY OIL (UNII: EP61SM69Z2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-417-02	1 in 1 BOX	07/02/2018
1	NDC: 76348-417-01	14 g in 1 BOTTLE, GLASS; 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	07/02/2018

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories Inc.		945739449	manufacture(76348-417)