NAIL RENU ANTIFUNGAL- miconazole nitrate 2% cream

NAIL RENU Antifungal by

Drug Labeling and Warnings

NAIL RENU Antifungal by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC., Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Miconazole Nitrate 2%

PURPOSE

Antifungal

INDICATIONS & USAGE

Uses

• proven clinically to cure most:
• athlete's foot (tinea pedis)
• ringworm (tinea corporis)
  
• Effectively soothes and relieves:
• itching
• burning
• cracking
  
• helps prevent most athlete's foot from coming back, with daily use
  

WARNINGS

For external use only

WHEN USING

When using this product, avoid contact with the eyes

STOP USE

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 effective on the scalp or nails

INACTIVE INGREDIENT

Benxoic Acid, Ceramide-3, Ceteareth-20, Cetearyl Alcohol, Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Dehydroacetic Acid, Deionized Water, Ethyl Macadamiate, Eucalyptol, Eugenia Caryophyllus (Clove) Bud Oil, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Fruit Oil, Origanum vulgare (Oregano) Leaf Oil, Propylene Glycol, Thymol, Tocopherol, Triethanolamine, Trimethylpentanediol Adipic Acid Copolymer, Xanthan Gum

DO NOT USE

Do not use on Children under 2 years of age unless directed by a doctor.

OTHER SAFETY INFORMATION

Other Information

Store at 68º - 77º (20 - 25 C)

STATEMENT OF IDENTITY

NAIL RENU

Miconazole Nitrate 2%

Antifungal Cream

DOSAGE & ADMINISTRATION

Directions

• Clean the affected area and dry thoroughly
• apply a thin coat over 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, change shoes and socks 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 effective on the scalp or nails

PRINCIPAL DISPLAY PANEL

TTUBE ARTWORK AND UNIT BOX ARTWORK FOR NAIL RENU

INGREDIENTS AND APPEARANCE

NAIL RENU ANTIFUNGAL 
miconazole nitrate 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-997
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	0.6 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WATER (UNII: 059QF0KO0R)
EUCALYPTOL (UNII: RV6J6604TK)
CLOVE OIL (UNII: 578389D6D0)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
THYMOL (UNII: 3J50XA376E)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
OLIVE OIL (UNII: 6UYK2W1W1E)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CINNAMON BARK OIL (UNII: XE54U569EC)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
CERAMIDE 3 (UNII: 4370DF050B)
TROLAMINE (UNII: 9O3K93S3TK)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-997-02	1 in 1 BOX	07/24/2023
1	NDC: 76348-997-01	28 g in 1 TUBE; 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	07/17/2023

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-997)