SIGNATURE BLACK BOTTLE TEA TREE ANTIFUNGAL FOOT AND BODY WASH- tolnaftate lotion 
Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle)

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Signature Black Bottle Tea Tree Antifungal Foot & Body Wash

Drug Facts

Active ingredients:

Tolnaftate 1.0%

Purpose:

Antifungal

Uses

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

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:

Label

SIGNATURE BLACK BOTTLE TEA TREE ANTIFUNGAL FOOT AND BODY WASH 
tolnaftate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69882-726
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69882-726-01266.16 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00502/10/2016
Labeler - Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) (071268228)

Revised: 11/2023
Document Id: 09d75c0c-2944-98b9-e063-6394a90aa287
Set id: 2c966d97-30f5-4942-b64d-742884ce6a2f
Version: 4
Effective Time: 20231110
 
Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle)