SIGNATURE BLACK BOTTLE TEA TREE ANTIFUNGAL FOOT AND BODY WASH- tolnaftate lotion

Signature Black Bottle Tea Tree Antifungal Foot and Body Wash by

Drug Labeling and Warnings

Signature Black Bottle Tea Tree Antifungal Foot and Body Wash by is a Otc medication manufactured, distributed, or labeled by Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients:

Tolnaftate 1.0%

Purpose:

Antifungal

Uses

• Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• Helps prevent most athlete's foot with daily use
• For effective relief of itching, burning and cracking

Warnings

For external use only

Do not use

on children under 2 years of age except under the advice and supervision of a doctor

When using this product

avoid contact with the eyes

Stop use and ask a doctor if:

• Irritation occurs
• There is no improvement within 4 weeks

Keep out of reach of children.

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

Directions

• Wash affected area and dry thoroughly
• Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
• Supervise children in the use of this product
• For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• Use daily for 4 weeks; if condition persists longer, ask a doctor
• Prevent athlete's foot, apply once or twice daily (morning and/or night
• This product is not effective on the scalp or nails

Inactive ingredients:

Acrylates copolymer, aqua (deionized water), cocamide MEA, cocamidopropyl betaine, disodium oleamido MEA sulfosuccinate, dl-panthenol, DMDM hydantoin, glycol stearate, isopropyl myristate, melaleuca alternifolia (australian tea tree) leaf oil, mentha piperita (peppermint) oil, origanum vulgare (oregano) leaf oil, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine.

Other information

Store between 20° to 25°C (68° to 77°F)

Package Labeling:

INGREDIENTS AND APPEARANCE

SIGNATURE BLACK BOTTLE TEA TREE ANTIFUNGAL FOOT AND BODY WASH 
tolnaftate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69882-726
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)
PANTHENOL (UNII: WV9CM0O67Z)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCOL STEARATE (UNII: 0324G66D0E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69882-726-01	266.16 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/10/2016

Labeler - Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) (071268228)