Label: FUNGI NAIL TOE AND FOOT- tolnaftate solution
- NDC Code(s): 55505-177-26, 55505-177-80
- Packager: Kramer Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 10, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions:
■ Clean affected areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid 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 the toes. ■ For athlete’s foot and ringworm, use daily for 4 weeks. For toe fungus, apply under nail and around cuticle area. If condition persists longer, consult a doctor. ■ To prevent athlete's foot, apply once or twice daily (morning and/or night). ■ This product is not effective on the scalp or nails. ■ Supervise children in the use of this product. - STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredient
Aloe Vera Leaf, Benzoic Acid, Caprylyl Glycol, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Citric Acid, Dimethicone 350, Ethylhexyl Glycerin, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil, Triethyl Citrate -
PRINCIPAL DISPLAY PANEL
MAXIMUM STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL
LIQUID
CLINICALLY PROVEN TO
CURE AND PREVENT
FUNGAL INFECTIONS
TRIPLE ACTION FORMULA
✓ Kills Fungus
✓ Stops Itching & Burning
✓ Restores Skin Health
* Cures Most Athlete's Foot
CLINICALLY PROVEN INGREDIENT
PLUS
Aloe & Tea Tree Oil
1 FL. OZ. (30mL)
Convenient and Easy to Apply
Deep Penetrating Medicine that Stays in Place
Not actual size.
Patent pending.
Maximum Strength Anti-Fungal
PLUS
5 natural oils:
○ aloe vera
○ tea tree
○ eucalyptol
○ lavender
○ olive oil
For best results treat skin around all toenails and in between toes.
Not for nail or scalp fungus.
Cures most athlete's foot.
For more information about Fungi-Nail® and money back guarantee, visit us at funginail.com
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894
K1120
MAXIMUM STRENGTH
ANTI-FUNGAL LIQUID
Maximum
Strength
Medicine
MAXIMUM STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL
SPRAY
CLINICALLY PROVEN TO
CURE AND PREVENT
FUNGAL INFECTIONS
TRIPLE ACTION FORMULA
✓ Kills Fungus
✓ Stops Itching & Burning
✓ Restores Skin Health
+ Cures Most Athlete's Foot
CLINICALLY PROVEN INGREDIENT
PLUS
Aloe & Tea Tree Oil
1 FL. OZ. (30mL)
MAXIMUM
STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL
SPRAY
Spray Applicator
Makes Application
Easy With No Mess
Deep Penetrating
Medicine that Stays
in Place
MAXIMUM
STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL
SPRAY
Infused with
5 natural oils
○ aloe vera
○ tea tree
○ eucalyptol
○ lavender
○ olive oil
For best results treat skin
around all toenails and in
between toes.
Not for nail or scalp fungus.
Cures most athlete's foot.
For more information
about Fungi-Nail® and
money back guarantee,
visit us at funginail.com
Kramer Laboratories, Inc. Bridgewater, NJ 08807
1-800-824-4894
K0622
MAXIMUM STRENGTH
FUNGI-NAIL®
ANTI-FUNGAL
SPRAY
CLINICALLY PROVEN TO
CURE AND PREVENT
FUNGAL INFECTIONS
1 FL OZ (30mL)
Distributed by:
KRAMER
LABORITORIES
K0622
Kramer Laboratories, Inc. Bridgewater, NJ 08807
kramerlabs.com funginal.com 1-800-824-4894
-
INGREDIENTS AND APPEARANCE
FUNGI NAIL TOE AND FOOT
tolnaftate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-177 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 mL Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Benzoic Acid (UNII: 8SKN0B0MIM) Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC) Citric Acid Monohydrate (UNII: 2968PHW8QP) Dimethicone 350 (UNII: 2Y53S6ATLU) Ethylhexylglycerin (UNII: 147D247K3P) Eucalyptol (UNII: RV6J6604TK) Glycerin (UNII: PDC6A3C0OX) Glyceryl Monostearate (UNII: 230OU9XXE4) Lavender Oil (UNII: ZBP1YXW0H8) Olive Oil (UNII: 6UYK2W1W1E) Phenoxyethanol (UNII: HIE492ZZ3T) Poloxamer 188 (UNII: LQA7B6G8JG) Water (UNII: 059QF0KO0R) Sodium Hydroxide (UNII: 55X04QC32I) Tea Tree Oil (UNII: VIF565UC2G) Triethyl Citrate (UNII: 8Z96QXD6UM) Caprylyl Glycol (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55505-177-26 1 in 1 CARTON 03/25/2019 1 30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 2 NDC:55505-177-80 1 in 1 CARTON 12/10/2022 2 30 mL in 1 BOTTLE, SPRAY; 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 03/25/2019 Labeler - Kramer Laboratories (122720675) Establishment Name Address ID/FEI Business Operations Denison Pharmecuticals 001207208 manufacture(55505-177)