Label: TOLNAFTATE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53210-1001-0 - Packager: Morales Distributors, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 28, 2012
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- Official Label (Printer Friendly)
- Active ingredient (in each gram)
- Purpose
- Uses
- Warnings
- Stop use and ask a doctor if
- Do not use
- Keep out of reach of children.
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Directions
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot, pay special attentional to 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
- to prevent athlete's foot, apply once or twice daily (morning and night)
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
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Package label
NDC NO. 53210-1001-0
Tolnafate 1 percent
Cream USP 1 percent AntifungalRelieves Itching and Burning
Cures and Prevents Athlete's Foot
Prevents and Relieves Itching and Redness
Anti-Itch Cream for Skin Irritations
Compare to Tinactin (R) active ingredient
This product is n ot manufactured or distributed by Schering-Plough Healthcare Products, Inc. owner of the registered Trademark TinactinMaximum Strength
Net 1 oz(28.3g)
Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682Made in Korea
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INGREDIENTS AND APPEARANCE
TOLNAFTATE
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53210-1001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) CHLOROCRESOL (UNII: 36W53O7109) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LIGHT MINERAL OIL (UNII: N6K5787QVP) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53210-1001-0 1 in 1 BOX 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/25/2012 Labeler - Morales Distributors, Inc. (127151731)