Tolnaftate: Package Insert and Label Information
TOLNAFTATE- tolnaftate cream
Cardinal Health 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.
Drug Facts
Active ingredient
Tolnaftate USP 1%
Purpose
Antifungal Cream
Uses
- Cures most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
- Relieves the itching, irratation, redness, scaling and discomfort which can accompany these conditions.
Warnings
- Do not use on children under 2 years of age unless directed by a doctor.
- For external use only avoid contact with eyes.
- Irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).
Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of the product over the 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.
- Change shoes and socks at least once daily.
- For athlete’s foot and ringworm, use daily for 4 weeks.
- For jock itch, use daily for 2 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
Other information
- Store at controlled room temperature 15°-30°C (59°-86°F).
- Close cap tighty after ever use.
Inactive ingredients
Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water
Questions?
1-800-222-1222
Principal Display Panel – 1.0 oz Tube
LEADER NDC 70000-0494-1
Compare to Tinactin
Antifungal Cream (Tolnaftate 1%)
CURES Most:
ATHLETE’S FOOT
Net Wt. 1.0 OZ (28 g)
Principal Display Panel – 1.0 oz Carton
LEADER NDC 70000-0494-1
Antifungal Cream (Tolnaftate 1%)
CURES Most:
ATHLETE’S FOOT
Net Wt. 1.0 OZ (28 g)
| TOLNAFTATE tolnaftate cream | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Labeler — Cardinal Health LLC (097537435) |
| Registrant — Sheffield Pharmaceuticals LLC (151177797) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sheffield Pharmaceuticals LLC | 151177797 | MANUFACTURE (70000-0494) | |
Revised: 01/2021 Cardinal Health LLC
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.