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Smooth Gator Fungus Eliminator

Dosage form: liquid
Ingredients: CLOTRIMAZOLE 10mg in 1mL
Labeler: Smooth Gator, LLC
NDC Code: 70673-747

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.

Smooth Gator Fungus Eliminator Solution

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:

SMOOTH GATOR FUNGUS ELIMINATOR 
clotrimazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70673-747
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
SAFFLOWER 
EMU OIL 
EUCALYPTUS OIL 
SOYBEAN OIL 
HELIANTHUS ANNUUS FLOWERING TOP 
LAVENDER OIL 
TEA TREE OIL 
PEPPERMINT OIL 
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES 
ALMOND OIL 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:70673-747-0159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/29/2016
Labeler - Smooth Gator, LLC (029819479)

 
Smooth Gator, LLC

Medically reviewed on Feb 7, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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