CLIXIT FOOT WIPES 3 PACK- tolnaftate foot wipe liquid

Clixit Foot Wipes 3 Pack by

Drug Labeling and Warnings

Clixit Foot Wipes 3 Pack by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Tolnaftate 1 percent

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

Clinically proven to prevent most fungal nail and skin infections

WARNINGS

Warnings

• Do not use on children under 2 years of age unless directed by a doctor
• Avoid contact with eyes, ears or mouth
• If irritation occurs, discontinue use and consult a doctor
• If swallowed, get medical help or consult a poison control center immediately

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INACTIVE INGREDIENT

Inactive Ingredients

Alcohol, Ethoxydiglycol, Glycerin, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Leaf Oil, Menthol, Menthy Lactate, PPG-20 Methyl Glucose Ether, Tocopherol, Trimethylpentanediol/Adipic Acid Copolymer

STATEMENT OF IDENTITY

3 packette box

DOSAGE & ADMINISTRATION

Antifungal wipes help wash away dirt debris and bacteria

PRINCIPAL DISPLAY PANEL

Single packette display panel

INGREDIENTS AND APPEARANCE

CLIXIT FOOT WIPES 3 PACK 
tolnaftate foot wipe liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-445
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.04 g  in 4 g

Inactive Ingredients
Ingredient Name	Strength
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ALCOHOL (UNII: 3K9958V90M)
TEA TREE OIL (UNII: VIF565UC2G)
MENTHOL (UNII: L7T10EIP3A)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
GLYCERIN (UNII: PDC6A3C0OX)
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
PEPPERMINT OIL (UNII: AV092KU4JH)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-445-03	1 in 1 BOX	10/02/2019
1	NDC: 76348-445-01	4 g in 1 PACKET; 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	10/02/2019

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-445)