SMOOTH GATOR FUNGUS ELIMINATOR- clotrimazole liquid

Smooth Gator Fungus Eliminator by

Drug Labeling and Warnings

Smooth Gator Fungus Eliminator by is a Otc medication manufactured, distributed, or labeled by Smooth Gator, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredients:

Clotrimazole 1.00%

Purpose:

Antifungal Treatment

Uses:

For the cure of most athlete’s foot (tinea pedis) ringworm (tinea corporis) jock itch (tinea cruris)
For relief of itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions.

Warnings:

• For external use only.

Ask a doctor before use

• on children under 2 years of age.

When using this product

• avoid contact with eyes.

Stop use and ask doctor if

Irritation occurs or there is no improvement within 4 weeks (2 weeks for jock itch).

KEEP OUT OF RICH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately

Directions:

Read all package directions and warnings before using.
Use only as directed.
Clean the affected area with soap and warm water and dry thoroughly.
Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.
Avoid applying to severely cracked or irritated areas.
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.
For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.
Supervise children in the use of this product.
Intended for use by normally healthy adults only.
Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.

Other information:

Apply to skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.

Inactive ingredients:

BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus(Eucalyptus) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

INGREDIENTS AND APPEARANCE

SMOOTH GATOR FUNGUS ELIMINATOR 
clotrimazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70673-747
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SAFFLOWER (UNII: 4VBL71TY4Y)
EMU OIL (UNII: 344821WD61)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SOYBEAN OIL (UNII: 241ATL177A)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
ALMOND OIL (UNII: 66YXD4DKO9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70673-747-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/29/2016

Labeler - Smooth Gator, LLC (029819479)