GOLD MOUNTAIN BEAUTY INTENSIVE REPAIR SERUM- tolnaftate antifungal lotion

Gold Mountain Beauty Intensive Repair Serum by

Drug Labeling and Warnings

Gold Mountain Beauty Intensive Repair Serum by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Effectively relieves cracking, scaling and soreness accompanying fungus (tinea pedis)

• Relieves Scaling and Cracking
• Cures and prevents foot fungus tinea pedis (athlete's foot)

Warnings

For external use only

• 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

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

• If irritation occurs, discontinue use and consult a doctor

Directions

Apply 1-2 pumps of serum onto each foot 2 times daily, paying special attention to rough areas.
For keeping skin smooth, apply 1 pump on each foot once a day
Supervise children in the use of this product

Other information

Store at room temperature (59 - 86 degrees F)

Inactive ingredients

Acetylated Lanolin Alcohol, Benzoic Acid, Cetyl Acetate, Cyclopentasiloane,

Deionized Water, Dimethicone Copolyl, Dimethiconol, Ethoxydiglycol, Glycerin,

Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil,

Hydroxyethylacrylate/Sodium Acryloyldimethyl Taurate copolymer, Menthol (and) Menthyl Lactate,

Olea Europaea (Olive) Oil, Phenoxyethanol, Phenyl Trimethicone, Polysorbate 60, Polysorbate 80,

Propylene Glycol, Squalane, Talc.

QUESTIONS

For questions or comments, please visit:

goldmountainbeauty.com

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

GOLD MOUNTAIN Beauty FOOT THERAPY INTENSE HYDRATION INTENSIVE REPAIR SERUM

INGREDIENTS AND APPEARANCE

GOLD MOUNTAIN BEAUTY INTENSIVE REPAIR SERUM 
tolnaftate antifungal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-418
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	2.8 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CETYL ACETATE (UNII: 4Q43814HXS)
2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TALC (UNII: 7SEV7J4R1U)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLIVE OIL (UNII: 6UYK2W1W1E)
SQUALANE (UNII: GW89575KF9)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
MENTHOL (UNII: L7T10EIP3A)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-418-02	1 in 1 BOX	07/02/2018
1	NDC: 76348-418-01	28 g in 1 BOTTLE, PLASTIC; 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(76348-418)