NATURAL FUSION ANTI-FUNGAL MEDI-GEL- tolnaftate gel

Natural Fusion Anti-fungal Medi-Gel by

Drug Labeling and Warnings

Natural Fusion Anti-fungal Medi-Gel by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• Tolnaftate 1%: Anti-fungal

Uses

• Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (thea corporis).
• Helps prevent most athlete's foot with daily use.
• For effective relief of itching, burning and cracking.

Warnings

For external use only.

DO NOT USE

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

WHEN USING

When using this product avoid contact with eyes.

STOP USE

Stop use and ask a doctor if Irritation occurs. There is no improvement within 4 weeks

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN

In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

Directions

• Clean affected areas with soap and warm water and dry thoroughly.
• Apply a thin layer of Natural Fusion ™ Antifungal Medi-Gel over affected area twice daily (morning and night) or as directed by a doctor.
• Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
• For athlete's foot pay special attention to spaces between toes.
• For athlete's foot and ringworm, use daily for 4 weeks.
• For toe fungus, apply under nail and around cuticle areas. If condition persists longer, consult a doctor.
• This product is not effective on the scalp or nails.
• Supervise children in the use of this product.

Other information

Store at controlled room temperature 15°-30° C (59°-86° F)
Protect from freezing. If freezing occurs warm to room temperature.

Inactive Ingredients

Purified Water, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Phenoxyethanol, Dimethicone 350, Glyceryl Monostearate, Poloxamer 188, Aloe Vera Leaf, Eucalyptol, Lavender Oil, Olive Oil, Tea Tree Oil, Sodium Hydroxide, D&C Green No. 5, D&C Yellow No. 10. 

Principal Display Panel

Kramer Labs

Natural
Fusion™

Science & Nature in Healing Harmony

Medi-Gel

ANTI-FUNGAL
1% TOLNAFTATE

Clinical Strength

Fungus Killing Medicine

Fused with:
Tea Tree Oil
Aloe
Lavender
Eucalyptus

Fast Absorbing Gel Alcohol Free

NET WT 1.25 OZ. (35.4 g)

Cures & prevents most athlete's foot & ringworm

Proven antifungal medicine PLUS the nurturing power of natural ingredients

Neutra pH™
TECHNOLOGY®

 Restores healthy skin
Helps restore skin's natural pH

*Patient Pending

Cura y previene la mayoría de casos de pie de atleta

Antimicótico elaborado en combinación con Aceite del Árbol de Té, Lavanda, Sábila y Eucalipto

TECHNOLOGĺA
Neutra pH™

Ayuda a restaurar el pH natural de la piel

Gel sin alcohol de rápida absorción

*Patente en Trámite

www.natural-fusion.com

Distributed by: Kramer Laboratories, Inc.
400 University Drive, Suite 400
Coral Gables, FL 33134

KRAMER
LABORATORIES

NDC# 55505-184-53

Kramer Labs

Natural
FUSION™

Science & Nature in Healing Harmony

Antifungal Medi-Gel

NET WT. 1.25 OZ.

Distributed By:
KRAMER
LABORATORIES

Kramer Laboratories, Inc. Coral Gabbles, FL 33134 U.S.A.

kramerlabs.com
fungi-nail.com
1-800-824-4894
K0317

INGREDIENTS AND APPEARANCE

NATURAL FUSION ANTI-FUNGAL MEDI-GEL  
tolnaftate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)
Phenoxyethanol (UNII: HIE492ZZ3T)
Dimethicone 350 (UNII: 2Y53S6ATLU)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Poloxamer 188 (UNII: LQA7B6G8JG)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Eucalyptol (UNII: RV6J6604TK)
Lavender Oil (UNII: ZBP1YXW0H8)
Olive Oil (UNII: 6UYK2W1W1E)
Tea Tree Oil (UNII: VIF565UC2G)
Sodium Hydroxide (UNII: 55X04QC32I)
D&c Green No. 5 (UNII: 8J6RDU8L9X)
D&c Yellow No. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-184-53	1 in 1 CARTON	08/01/2017
1		35.4 g in 1 TUBE; 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	08/01/2017

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(55505-184)