Label: NAIL RENU- tolnaftate 1% solution
- NDC Code(s): 76348-995-01, 76348-995-05
- Packager: RENU LABORATORIES, INC.
- 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 March 22, 2023
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- Official Label (Printer Friendly)
- PURPOSE
-
INDICATIONS & USAGE
Uses
- proven clinically to cure most Fungal nail and Skin infections including athlete's foot (tinea pedis) and ringworm (tinea corporis)
- Effectively relieves itching, burning, cracking and scaling associated with the above conditions.
- helps prevent most athlete's foot from coming back with daily use
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
-
INSTRUCTIONS FOR USE
Directions:
- clean the affected area and dry thoroughly
- apply a thin layer over the affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- use daily for 4 weeks. If condition lasts longer, ask a doctor
- to prevent athlete's foot, apply to the feet once or twice daily
- this product is not intended for/or effective on the scalp.
- OTHER SAFETY INFORMATION
- QUESTIONS
-
INACTIVE INGREDIENT
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
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NAIL RENU
tolnaftate 1% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-995 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-995-01 1 in 1 BOX 03/22/2023 1 NDC:76348-995-05 15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 03/22/2023 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-995)