NAIL RENU- tolnaftate 1% solution 
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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NAIL RENU ANTIFUNGAL SOLUTION

Purpose

Antifungal

Uses

Warnings

Stop use and ask a doctor if

KEEP OUT OF REACH OF CHILDREN

If Pregnant or breastfeeding ask a health professional before use.

Directions:

Other information

Questions or Comments

267-482-0866

www.nailrenu.com

Inactive Ingredients

C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonum Zeylanicum (Cinnamon) Bark Oil, Cymbopogon Nardus (Citronella) Oil, Ethoxydiglycol, Eugenia Caryophyllum (Clove) Bud Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Lavandula Angustifolia (Lavender) Oil, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive Pomace) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Pinene, Prunus Amygdallus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromatique (Clove) Bud Oil, Thymol, Tocopherol (Vitamin E), Trimethylpentanediol-Adipic Acid Copolymer

Directions

Tolnaftate

Nail RENU LABEL ART

AND

NAIL RENU

BOX ART

NRFungal Label 2

NailRenu Box

NAIL RENU 
tolnaftate 1% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-995
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CERAMIDE 3 (UNII: 4370DF050B)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CLOVE OIL (UNII: 578389D6D0)  
THYMOL (UNII: 3J50XA376E)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
CLOVE (UNII: K48IKT5321)  
TEA TREE OIL (UNII: VIF565UC2G)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PINENE (UNII: 996299PUKB)  
JOJOBA OIL (UNII: 724GKU717M)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALMOND OIL (UNII: 66YXD4DKO9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-995-011 in 1 BOX03/22/2023
1NDC:76348-995-0515 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00503/22/2023
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-995)

Revised: 3/2023
Document Id: f1877b83-30fd-7c8f-e053-2a95a90a7d1b
Set id: f1877b83-30fc-7c8f-e053-2a95a90a7d1b
Version: 1
Effective Time: 20230322
 
RENU LABORATORIES, INC.