NATUREPLEX TOLNAFTATE  ANTIFUNGAL- tolnaftate cream 
Natureplex, LLC

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.

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NATUREPLEX™ TOLNAFTATE
ANTIFUNGAL CREAM

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only.

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

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or, contact a Poison Control Center right away: 800-222-1222.

Directions

Other information

Inactive ingredients

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol, petrolatum

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Natureplex

TOLNAFTATE

Antifungal Cream

NET WT. 1 Oz. (28g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
NATUREPLEX TOLNAFTATE   ANTIFUNGAL
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 (UNII: I835H2IHHX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHLOROCRESOL (UNII: 36W53O7109)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-032-011 in 1 CARTON09/23/1993
128 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C09/23/1993
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-032)

Revised: 12/2017
Document Id: c2258205-0c1d-4535-a590-8ca5f9cc0da4
Set id: 575b8645-9166-4242-a74f-f4aa4acaaf3d
Version: 2
Effective Time: 20171205
 
Natureplex, LLC