TOPCARE  TOLNAFTATE ANTIFUNGAL- tolnaftate cream 
Topco Associates 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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TopCare®
Tolnaftate Antifungal Cream

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

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

For external use only.

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

If pregnant of breastfeeding, ask a health professional before use.

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, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Questions or comments?

866-323-0107 or www.natureplex.com

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

NDC 36800-052-60

TopCare
health

PRESCRIPTION STRENGTH

Athlete's Foot Cream

TOLNAFTATE CREAM 1% • ANTIFUNGAL

• OUR PHARMACISTS •
RECOMMEND

NET WT 0.5 OZ (14 g)

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton
TOPCARE   TOLNAFTATE ANTIFUNGAL
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-052
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
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Polyethylene glycol 400 (UNII: B697894SGQ)  
Polyethylene glycol 3350 (UNII: G2M7P15E5P)  
titanium dioxide (UNII: 15FIX9V2JP)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-052-601 in 1 CARTON02/17/2006
114.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C02/17/2006
Labeler - Topco Associates LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(36800-052)

Revised: 12/2020
Document Id: cbbdbcd1-b4ad-4e7c-a90e-f71d56cade04
Set id: aba4ce9a-ae88-4223-b20f-d7897f7c2232
Version: 4
Effective Time: 20201202
 
Topco Associates LLC