DR CANUSO FUNGAL NAIL ERASER- tolnaftate oil oil 
Renu Laboratories, Inc.

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.

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Dr. CANUSO fungal nail eraser

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

KEEP OUT OF REACH OF CHILDREN

If pregnant or breastfeeding ask a health Professional before use

Directions

Inactive Ingredients

Cinnamomum Zeylanicum (Cinnamon Leaf) Oil, Ethoxydiglycol, Ethyl Macadamiate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive Oil), Trimethylpentanediol/Adipic Acid Copolymer.

Questions or Comments?

Visit www.DrCanuso.com

Uses

LABEL FOR BOTTLED PRODUCT

Multi Layer LABEL

Product BOX

7915 Nail Eraser Box

DR CANUSO FUNGAL NAIL ERASER 
tolnaftate oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.3 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
TEA TREE OIL (UNII: VIF565UC2G)  
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-410-021 in 1 BOX08/11/2015
114 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/11/2015
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-410)

Revised: 1/2022
Document Id: d57c0e4a-ee73-e438-e053-2a95a90aeda5
Set id: 2083f9ed-09d6-26e6-e054-00144ff88e88
Version: 9
Effective Time: 20220113
 
Renu Laboratories, Inc.