Nailrenew (62858-101)

Nailrenew (62858-101)
SPL v8
SPL
SPL Set ID a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5
Route
TOPICAL
Published
Effective Date 2014-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Water Polyethylene Glycol 400 Glyceryl Monostearate Cetostearyl Alcohol Ceteth-20 Phosphate Dihexadecyl Phosphate Propylene Glycol Aloe Vera Leaf Coco-betaine Octoxynol-9 Cetyl Alcohol Stearyl Alcohol Hydroxyethyl Cellulose (100 Mpa.s At 2%) Imidurea Benzyl Alcohol Propylparaben Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-22

Description

ACTIVE INGREDIENT TOLNAFTATE 1.0%


Medication Information

Warnings and Precautions

WARNINGS

  • For external use only.
  • In case of accidental ingestion contact a physician, emergency medical care facility or poison control center.
  • Stop use and ask a physician if rash or irritation occurs.
Indications and Usage

USES

  • Helps cure most fungal nail and skin infections, including Tinea Corporis (Ringworm) and Tinea Pedis (Athlete's Foot).
  • Effectively relieves itching, burning, cracking and scaling accompanying the above conditions.
Dosage and Administration

DIRECTIONS

  • Clean affected area with soap and warm water and dry thoroughly.
  • Apply 2-3 drops twice daily (morning & evening) to affected areas; especially around free edges of nails (under tips) and cuticles and the space around the toes.
  • Allow solution to soak into nail or skin.
  • This product is not effective on scalp or hair.
  • Application to adjacent nails is recommended to prevent the spread of the infection. Keep affected areas clean and dry throughout the day.
Description

ACTIVE INGREDIENT TOLNAFTATE 1.0%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 50570-1

DO NOT USE

  • ON CHILDREN UNDER 2 UNLESS DIRECTED BY A DOCTOR.
  • NEAR OR IN EYES, EARS OR MOUTH.
Section 51727-6

Water (Aqua), PEG-8, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Propylene Glycol, Aloe Barbadensis Leaf Juce, Coco-betaine, Octoxynol-9, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethylcellulose, Imidazolidinyl Urea, Benzyl Alcohol, Propylparaben, Triethanolamine

Section 51945-4

Section 53413-1

QUESTIONS? EMAIL: [email protected]

Section 55105-1

PURPOSE

ANTIFUNGAL

Section 55106-9

ACTIVE INGREDIENT

TOLNAFTATE 1.0%


Structured Label Content

Indications and Usage (34067-9)

USES

  • Helps cure most fungal nail and skin infections, including Tinea Corporis (Ringworm) and Tinea Pedis (Athlete's Foot).
  • Effectively relieves itching, burning, cracking and scaling accompanying the above conditions.
Dosage and Administration (34068-7)

DIRECTIONS

  • Clean affected area with soap and warm water and dry thoroughly.
  • Apply 2-3 drops twice daily (morning & evening) to affected areas; especially around free edges of nails (under tips) and cuticles and the space around the toes.
  • Allow solution to soak into nail or skin.
  • This product is not effective on scalp or hair.
  • Application to adjacent nails is recommended to prevent the spread of the infection. Keep affected areas clean and dry throughout the day.
Warnings and Precautions (34071-1)

WARNINGS

  • For external use only.
  • In case of accidental ingestion contact a physician, emergency medical care facility or poison control center.
  • Stop use and ask a physician if rash or irritation occurs.
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 50570-1 (50570-1)

DO NOT USE

  • ON CHILDREN UNDER 2 UNLESS DIRECTED BY A DOCTOR.
  • NEAR OR IN EYES, EARS OR MOUTH.
Section 51727-6 (51727-6)

Water (Aqua), PEG-8, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Propylene Glycol, Aloe Barbadensis Leaf Juce, Coco-betaine, Octoxynol-9, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethylcellulose, Imidazolidinyl Urea, Benzyl Alcohol, Propylparaben, Triethanolamine

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

QUESTIONS? EMAIL: [email protected]

Section 55105-1 (55105-1)

PURPOSE

ANTIFUNGAL

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

TOLNAFTATE 1.0%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)